FDA event 98793 · Recall Observatory

device · product 1 of 35

PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU

Z-2363-2026

Recall number: Z-2363-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 50,724

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): AK-00376/10801902197938, 10801902193275, 10801902197938, 10801902197952/33F24D0004, 33F24E0166, 33F24G0318, 33F24J0486, 33F24K0083, 33F24L0725, 33F25A0453, 33F25A0610, 33F25C0749, 33F25C0906, 33F25E0031, 33F25G0075, 33F25H0007, 33F25H0719, 33F25J0739, 33F25J0817, 33F25L0462, 33F25M0954, 33F26B0949, 33F26C0575, 33F24A0016; ASK-00376-VCU/10801902193275, 10801902138788/33F24L0522, 33F24M0088, 33F25C0060, 33F25D0282, 33F25F0257, 33F25G0746, 33F25J0602, 33F24D0201

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 2 of 35

Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS; STIMUCATH SFTY KIT: 20G CTH, 18Gx8CM NDL/AB-20608-KS; STIMUCATH KIT: 19G CATH, 17G x 9CM NDL/AB-05060-PK; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/ASK-19609-VCU; CONTINUOUS NERVE BLOCK KIT/ASK-19600-CC2; CONTINUOUS NERVE BLOCK KIT 19 GA X 60/ASK-19608-CC; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-KP; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-SHC; FLEXBLOCK KIT:ECHO CATH, 17Gx8CM STM NDL/FB-19608-K; FLEXBLOCK ULTRASOUND KIT: 17Gx8CM STM ND/FB-19608-KU; FLEXBLOCK KIT:ECHO CATH, 17Gx9CM NS NDL/FB-19609-K; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/FB-19609-KU; CONTINUOUS PERIPHERAL NERVE BLOCK KIT/ASK-19608-US1; EPIDURAL CATHETERIZATION KIT/ASK-05001-SLR1; EPIDURAL CATHETERIZATION KIT/MH-05001; EPIDURAL CATHETERIZATION KIT/WJ-05401; SPINAL ANES/EPIDURAL CATH 19GA X 90CM/ASK-05501-USC1; EPIDURAL NEEDLE KIT/LG-03000; EPIDURAL ANESTHESIA KIT/MTO-03000-VM; EPIDURAL ANESTHESIA KIT/SM-03001; Anesthesia conduction kit/FB-19611-K

Z-2364-2026

Recall number: Z-2364-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 205,685

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): ASK-04001-SUH-S/10801902210217, 10801902193275/33F25C0766, 33F25E0112, 33F25G0101, 33F25H0058, 33F25H0725, 33F25J0862, 33F25M0836, 33F25F0160; ASK-04001-VM1/10801902210217, 10801902202106, 10801902193275/33F24L0599, 33F26A0962, 33F24G0280; AB-19604-KS/10801902210217, 10801902209471/33F24L0608, 33F25G0474, 33F25J0814, 33F25M0887, 33F24D0064; AB-19608-KS/10801902210217, 10801902209471/33F24E0312, 33F24F0295, 33F24G0316, 33F24K0082, 33F24L0714, 33F25E0027, 33F25E0904, 33F25H0003, 33F25J0815, 33F25L0337, 33F26B0498, 33F24E0314; AB-20608-KS/)10801902210217/33F25H0004, 33F25J0816, 33F24D0437; AB-05060-PK/10801902209433, 10801902210217/33F24D0002, 33F24E0029, 33F24G0315, 33F24J0484, 33F24K0081, 33F25A0451, 33F25C0747, 33F25E0026, 33F25J0646, 33F24E0028; ASK-19609-VCU/10801902210217, 10801902206876, 10801902214291/33F24E0536, 33F24J0630, 33F24L0605, 33F25C0179, 33F25E0220, 33F25H0140, 33F26B1003, 33F24D0628; ASK-19600-CC2/10801902210057, 10801902210217, 10801902210064/33F24D0393, 33F24E0533, 33F24G0494, 33F24K0251, 33F24L0665, 33F25C0177, 33F25E0217, 33F25H0138, 33F24C0230; ASK-19608-CC/10801902210217, 10801902210064, 10801902202236/33F24G0309, 33F24K0252, 33F24L0639, 33F25B0691, 33F25C0178, 33F25C0761, 33F25E0218, 33F25E1022, 33F25H0750, 33F25J0918, 33F26B0230, 33F24D0394; ASK-19608-KP/10801902210217/33F24G0495, 33F24G0086; ASK-19608-SHC/10801902210217, 40801902202220, 10801902202243/33F24G0496, 33F24J0629, 33F24K0253, 33F24L0573, 33F25A0571, 33F25C0733, 33F25E0219, 33F25G0757, 33F25H0139, 33F25J0919, 33F25K0400, 33F25L0480, 33F26B0606, 33F24C0231; FB-19608-K/10801902210217, 10801902210125/33F24G0533, 33F24J0650, 33F24K0279, 33F24L0568, 33F25C0186, 33F25C0748, 33F25E0257, 33F25G0147, 33F25H0164, 33F25J0623, 33F25L0340, 33F25M0847, 33F24C0258; FB-19608-KU/10801902210217, 10801902210132/33F24E0026, 33F24E0574, 33F24G0312, 33F24J0328, 33F24L0557, 33F24M0268, 33F25C0187, 33F25C0940, 33F25E0258, 33F25H0165, 33F25J0624, 33F25L0344, 33F25M0851, 33F23G0580; FB-19609-K/10801902210132, 10801902210217, 10801902210132, 10801902210149/33F24C0259, 33F24D0407, 33F24E0575, 33F24G0534, 33F24K0281, 33F24L0805, 33F25C0721, 33F25E1042, 33F25J0625, 33F25L0351, 33F25M0856, 33F26B0504, 33F24B0386; FB-19609-KU/10801902210149, 10801902210217, 10801902210149, 10801902193275/33F24C0260, 33F24E0576, 33F24E0577, 33F24G0535, 33F24L0763, 33F25A0592, 33F25E0259, 33F25E1043, 33F25H0758, 33F25K0402, 33F25L0471, 33F26B0594, 33F26C0480, 33S24L0763, 33F24L0738; ASK-19608-US1/10801902210217/33F24E0535, 33F24K0254, 33F24L0770, 33F24E0014; ASK-05001-SLR1/10801902210217, 10801902209617/33F24J0596, 33F24L0560, 33F25A0546, 33F25C0939, 33F25E0177, 33F25E0998, 33F25J0530, 33F24C0194; MH-05001/10801902210217/33F24G0540, 33F24J0331, 33F24J0654, 33F25E0261, 33F25H0168, 33F25J0937, 33F25L0478, 33F24K0286; WJ-05401/10801902210385, 10801902210217, 10801902210385/33F24B0166, 33F24C0054, 33F24J0672, 33F24K0307, 33F24L0548, 33F25A0609, 33F25A0625, 33F25C0723, 33F25E0285, 33F25E1062, 33F25G0156, 33F25H0187, 33F25J0640, 33F25J0952, 33F25L0414, 33F26B0559, 33F26C0858; ASK-05501-USC1/10801902210217, 10801902214857, 10801902209853/33F24E0506, 33F24E0507, 33F24G0478, 33F24L0561, 33F25A0561, 33F25C0167, 33F25C0769, 33F25E0200, 33F25G0132, 33F25H0745, 33F25J0908, 33F25L0412, 33F26B0557, 33F24C0211; LG-03000/10801902210217/33F24L0668, 33F24E0581; MTO-03000-VM/10801902210217, 10801902202076, 10801902119916/33F24E0586, 33F24G0547, 33F24J0658, 33F24K0291, 33F24L0632, 33F25A0596, 33F25C0869, 33F25E0265, 33F25H0173, 33F25J0939, 33F25L0380, 33F26C0306, 33F24A1057; SM-03001/10801902210217, 10801902202496, 10801902210354/33F24E0779, 33F24J0243, 33F24J0434, 33F24M0012, 33F25A0099, 33F25B0035, 33F25B0128, 33F25C0410, 33F25C0521, 33F25F0421, 33F25G0531, 33F25J0053, 33F25L0171, 33F26B0643, 33F24C0276; FB-19611-K/10801902210156/33F24F0014

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 3 of 35

Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU

Z-2365-2026

Recall number: Z-2365-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 14,840

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): ASK-09458-AH/10801902203172, 10801902193275, 10801902203172/33F24C0359, 33F24C1122, 33F24E0323, 33F24F0780, 33F24K0397, 33F25A0208, 33F25B0518, 33F25D0001, 33F25D0338, 33F25D0465, 33F25E0528, 33F25H0610, 33F25J0353, 33F25K0076, 33F25K0091, 33F25M0173, 33F26A1538, 33F26B0819, 33F24H0227; ASK-09458-COC/10801902193275, 10801902221084, 10801902216394/33F24K0755, 33F25C0380, 33F25D0590, 33F25H0583, 33F25J0354, 33F25K0125, 33F25M0243, 33F25M0393, 33F26A1535, 33F26B0404, 33F24F0732; ASK-09458-EUH/10801902193275, 10801902216394/33F24L0908, 33F25E0715, 33F25F0096, 33F25G0215, 33F25J0144, 33F25M0118, 33F26A1515, 33F26B0862, 33F24H0125; ASK-09458-SD/10801902193275, 10801902215014/33F25D0398, 33F25F0165, 33F25M0692, 33F26C0488; ASK-09458-VU/10801902217261, 10801902193275, 10801902217261, 10801902193275/33F24C0832, 33F24D0624, 33F24F0650, 33F24K0752, 33F24L0916, 33F25D0534, 33F25E0531, 33F25F0141, 33F25H0588, 33F25K0127, 33F25M0177, 33F26B0134, 33F26B0477, 33F26C0487, 33F24H0099

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 4 of 35

Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM

Z-2366-2026

Recall number: Z-2366-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 15,915

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): AI-06210-KS/10801902210217, 10801902211504/33F24G0127, 33F24H0302, 33F25E0321, 33F26A1322, 33F25B0008; AI-07155-KS/10801902210217, 10801902211481, 10801902197938/33F25B0056, 33F25C0574, 33F25D0190, 33F25D0688, 33F25E0387, 33F25E0467, 33F25E1140, 33F25E1211, 33F25G0708, 33F25H0269, 33F25H0319, 33F25H0357, 33F25J0606, 33F25L0085, 33F25L0313, 33F26A0018, 33F26A1258, 33F26A1305, 33F26B0256, 33F26B0731, 33F26B0938, 33F26C0063, 33F26C0271, 33F26C0537, 33F24D0003; ASK-07155-UPM/10801902210217, 10801902203172/33F25E0208, 33F25H0134, 33F25J0913, 33F25M0051, 33F23L0622

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 5 of 35

Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHS1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU13; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UNHS1

Z-2367-2026

Recall number: Z-2367-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 11,358

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): DLX-45563-VPSB/10801902193275/33F25C0704, 33F25D0316, 33F25D0627, 33F25M0094, 33F24L0860; DLX-45563-VPSC/10801902193275, 10801902208658, 10801902210118/33F25B0509, 33F25C0340, 33F25D0255, 33F25D0628, 33F25E0767, 33F25E0901, 33F25F0227, 33F25J0448, 33F25K0036, 33F26C0104, 33F26C0107, 33F24C0257; ASK-04001-UCHD1/10801902193275, 10801902219005/33F25H0415, 33F25J0349, 33F26B0440, 33F24L0396; ASK-04001-UCHS1/10801902193275, 10801902219067/33F24L1083, 33F25D0331, 33F25E0521, 33F25E0846, 33F25K0068, 33F25K0107, 33F25M0133, 33F26A1417, 33F26C0029, 33F24K0406; ASK-04001-DU13/10801902193275, 10801902201970/33F25B0514, 33F25C0703, 33F25F0090, 33F25F0124, 33F25H0421, 33F25J0197, 33F26A1372, 33F26B0850, 33F26C0369, 33R25A0227, 33F24K0314; ASK-04001-UNHS1/10801902193275, 10801902211887, 10801902158854/33F25A0229, 33F25C0714, 33F25D0390, 33F25E0847, 33F25G0244, 33F25M0129, 33F26A1139, 33F26C0370, 33F24E0400

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 6 of 35

Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A; ARTERIAL LINE KIT/AK-04510-S; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HUMC; ARTERIAL LINE KIT: 18 GA X 6 IN (16 CM)/ASK-04018-OH1; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-BID; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-MAR; ARTERIAL LINE KIT: 20 GA X 5 IN/ASK-04020-PM4; RA CATH KIT: 20 GA X 1 1/2IN (3.81 CM)/ASK-04120-HF3; RA CATH SET: 20 GA X 2 1/2 IN (6.35 CM)/ASK-04120-UR; ARTERIAL CATH KIT: 20 GA X 3 1/16 IN/ASK-04125-MGH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04500-HFH4; ARTERIAL LINE KIT: 20GA X 5IN/ASK-04510-BID2; ARTERIAL LINE KIT: 20GA X 5IN (12 CM)/ASK-04510-EHP1; ARTERIAL LINE KIT/ASK-04510-FEM1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-HFH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04510-HFH4; ARTERIAL LINE KIT/ASK-04510-SE; ARTERIAL LINE KIT: 20 GA X 5 IN (12CM)/ASK-04510-TGH2; RA CATH KIT: 20 GA X 12 CM/NA-04550-1A; RA CATH KIT: 20 GA X 12 CM/NA-04550-X1A; RA CATH KIT: 18 GA X 1-3/4IN/AK-04018; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-C; RA CATH KIT: 20 GA X 1-1/2IN/AK-04120; RA CATH KIT: 22 GA X 1-3/8IN/AK-04122; RA CATH KIT: 20 GA X 1-1/2IN/AK-04220; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-AH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-ATH; RA CATH KIT: 20 GA X 1 3/4IN (4.45CM)/ASK-04020-AU2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-BHS; ARTERIAL CATHETERIZATION KIT/ASK-04020-BIDB2; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-CCD1; ARTERIAL CATHETERIZATION KIT/ASK-04020-CR; ART LINE KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-EUH2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FAM1; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FMC; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-KSF2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LM; RA CATH KIT: 20 GA X 1 3/4IN/ASK-04020-MCH1; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MIH1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-NWMX; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-PHP; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-RIHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-RMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-RU; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-SE; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-SHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-SRMC1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UCL1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-UMI; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-UN; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC1; RA CATH SET: 20 GA X 1-1/2IN (3.81CM)/ASK-04220-PSU; RA CATH KIT: 20 GA X 1-1/2 IN (3.81 CM)/ASK-04220-UCL1; RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-S1A; CVC KIT: 20 GA X 5 IN (12CM)/ASK-04550-JMC1; ARTERIAL ACCESS TRAY/ASK-04001-BW2; ARTERIAL ACCESS TRAY WITH .025 IN SWG/ASK-04001-WUH1; ARTERIAL LINE KIT/ASK-04510-HUM

Z-2368-2026

Recall number: Z-2368-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 785,999

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): TJ-04020-1/10801902193275, 30801902202155/33F24J0338, 33F25A0158, 33F25C0753, 33F25E0281, 33F24B0409; NA-04220-S1A/10801902193275/33F25E1052, 33F24G0553; AK-04510-S/10801902192230, 10801902193275, 10801902196719/33F24A0337, 33F24A0338, 33F24A0339, 33F24A0341, 33F24A0342, 33F24A0343, 33F24A1012, 33F24B0107, 33F24B0108, 33F24B0109, 33F24B0110, 33F24B0111, 33F24C0010, 33F24C0011, 33F24D0015, 33F24D0016, 33F24E0046, 33F24E0047, 33F24G0327, 33F24G0570, 33F24G0571, 33F24G0572, 33F24G0573, 33F24G0574, 33F24G0575, 33F24J0493, 33F24J0674, 33F24J0675, 33F24J0676, 33F24J0677, 33F24K0091, 33F24K0309, 33F24K0313, 33F24L0623, 33F24L0627, 33F24L0629, 33F24L0631, 33F24L0754, 33F24L0783, 33F25A0457, 33F25A0613, 33F25A0614, 33F25A0615, 33F25A0616, 33F25C0738, 33F25C0751, 33F25C0794, 33F25C0846, 33F25C0907, 33F25C0955, 33F25C0956, 33F25E0040, 33F25E0288, 33F25E0289, 33F25E0290, 33F25E0910, 33F25E1065, 33F25E1066, 33F25G0079, 33F25G0158, 33F25H0012, 33F25H0193, 33F25H0194, 33F25H0195, 33F25H0196, 33F25J0464, 33F25J0642, 33F25J0789, 33F25J0801, 33F25J0802, 33F25J0803, 33F25J0804, 33F25L0486, 33F25L0488, 33F26B0668, 33F26B0669, 33F26B0671, 33F26B0672, 33F23L0360; ASK-04018-HUMC/10801902193275/33F25B0360, 33F25K0050, 33F25M0680, 33F25E1176; ASK-04018-OH1/10801902117622, 10801902193275, 10801902117622, 10801902117639/33F24F0741, 33F24L0218, 33F24L0865, 33F25B0173, 33F25C0253, 33F25E0667, 33F25F0162, 33F25J0143, 33F26A1440, 33F26B0794, 33F24A0112; ASK-04020-BID/10801902211429, 10801902193275, 10801902211429/33F24D0870, 33F24E0650, 33F24F0646, 33F24L0220, 33F24L0399, 33F25B0175, 33F25D0335, 33F25E0668, 33F25G0248, 33F25L0123, 33F26A0254, 33F26A1441, 33S23J0777, 33F24G0405; ASK-04020-MAR/10801902193275, 10801902159776/33F24J0567, 33F24L0586, 33F25A0519, 33F25E0136, 33F25E0979, 33F25G0675, 33F25J0504, 33F25L0210, 33F26B0742, 33F25K0032; ASK-04020-PM4/10801902138498, 10801902193275, 10801902138498, 30801902158896/33F24E0428, 33F24E0429, 33F24G0424, 33F24K0188, 33F24L0789, 33F25C0142, 33F25C0821, 33F25E0142, 33F25H0085, 33F25J0883, 33F25L0470, 33F26B0659, 33F24F0095; ASK-04120-HF3/10801902200447, 10801902193275, 10801902200447, 10801902117943/33F24D0857, 33F24F0638, 33F24H0168, 33F24K0389, 33F24L0289, 33F25D0336, 33F25F0126, 33F25F0163, 33F25H0616, 33F25J0202, 33F25M0158, 33F25M0362, 33F26A1429, 33F26B0127, 33S24A1516, 33S24C0854, 33F24A0136; ASK-04120-UR/10801902117943, 10801902193275, 10801902117943/33F24A0769, 33F24B0278, 33F24C0175, 33F24D0140, 33F24E0447, 33F24G0287, 33F24K0201, 33F25B0692, 33F25C0962, 33F25E0156, 33F25H0097, 33F25J0889, 33F25L0383, 33F26C0309, 33F24G0441; ASK-04125-MGH/10801902193275, 10801902139976/33F24J0584, 33F25C0985, 33F25D0307, 33F25E0157, 33F25E0990, 33F25H0098, 33F25J0519, 33F25L0421, 33F26A1057, 33F26B0983, 33F24K0203; ASK-04500-HFH4/10801902200461, 10801902193275, 10801902118001/33F24E0651, 33F24F0722, 33F24L0292, 33F25C0437, 33F25D0228, 33F25E0775, 33F25F0109, 33F25F0164, 33F25H0615, 33F25M0345, 33F26A1363, 33F26B0405, 33S24C0436, 33S24L0292, 33F24A0141; ASK-04510-BID2/10801902193275, 10801902211412, 10801902115024/33F24J0171, 33F25A0165, 33F25C0438, 33F25D0229, 33F25E0852, 33F25G0249, 33F25J0204, 33F25M0233, 33F26A1443, 33F26B0410, 33F24F0820; ASK-04510-EHP1/10801902193275, 10801902115024/33F24L0293, 33F25C0192, 33F25D0230, 33F25E0589, 33F25E0853, 33F25H0646, 33F25L0125, 33F26A0255, 33F26A1520, 33F26B0838, 33F24J0303; ASK-04510-FEM1/10801902214796, 10801902193275/33F24A0831, 33F24B0286, 33F24C0185, 33F24E0456, 33F24E0457, 33F24G0448, 33F24J0304, 33F24L0771, 33F25A0539, 33F25E0165, 33F25G0118, 33F25J0523, 33F26A1051, 33F26B0658, 33F24J0591; ASK-04510-HFH/10801902115031, 10801902193275, 10801902200454/33F24G0053, 33F24L0022, 33F24M0108, 33F24M0190, 33F25A0126, 33F25A0356, 33F25A0384, 33F25B0043, 33F25D0200, 33F25H0329, 33F25H0848, 33F25J0613, 33F26A1358, 33F26B0677, 33F24D0865; ASK-04510-HFH4/10801902200454, 10801902193275/33F24F0865, 33F24J0167, 33F24L0965, 33F25A0236, 33F25C0260, 33F25E0776, 33F25G0332, 33F25J0205, 33F25M0276, 33F26A0305, 33F26B0194, 33F24J0306; ASK-04510-SE/10801902193275, 20801902214038, 10801902217018/33F24K0213, 33F24L0592, 33F25B0251, 33F25C0159, 33F25E0171, 33F25J0527, 33F25L0333, 33F26B0664, 33F24A0873; ASK-04510-TGH2/10801902217018, 10801902193275, 10801902118070/33F24B0292, 33F24C0188, 33F24E0463, 33F24G0289, 33F24K0214, 33F24L0633, 33F25A0542, 33F25C0879, 33F25E0172, 33F25G0120, 33F25J0528, 33F25L0354, 33F25M0862, 33F24C0189; NA-04550-1A/30801902117367, 10801902193275, 33F24A1562, 33F24C0709, 33F24D0331, 33F24E0628, 33F24F0946, 33F24K0382, 33F24L0144, 33F24L1015, 33F25C0223, 33F25D0320, 33F25E0512, 33F25E0663, 33F25E0839, 33F25J0187, 33F25K0199, 33F24K0374; NA-04550-X1A/10801902193275, 30801902117374, 10801902119930/33F24K0704, 33F24L0145, 33F24L1138, 33F25C0465, 33F25C0472, 33F25D0633, 33F25G0387, 33F25J0188, 33F25K0200, 33F26C0354, 33F26C0763, 33F24A1326; AK-04018/10801902190915, 10801902193275, 10801902190939/33F24E0696, 33F24L0051, 33F25A0353, 33F25B0078, 33F25D0714, 33F25G0732, 33F25J0593, 33F26B0039, 33F24A1251; AK-04020/10801902190939, 10801902193275, 60801902121549, 10801902121551/33F24C0727, 33F24C1254, 33F24D0439, 33F24E0697, 33F24F0010, 33F24G0049, 33F24G0116, 33F24G0220, 33F24G0645, 33F24G0646, 33F24G0680, 33F24H0064, 33F24J0013, 33F24J0457, 33F24K0033, 33F24M0004,33F24M0052, 33F24M0070, 33F24M0103,33F24M0146,33F25A0084, 33F25A0335, 33F25A0346, 33F25A0362, 33F25A0397, 33F25B0080, 33F25B0307, 33F25B0414, 33F25C0058, 33F25C0097, 33F25C0494, 33F25C0575, 33F25D0027, 33F25D0083, 33F25D0102, 33F25D0296, 33F25D0703, 33F25F0293, 33F25F0398, 33F25G0493, 33F25H0322, 33F25H0842, 33F25J0037, 33F25J0767, 33F25K0276, 33F25L0154, 33F25L0169, 33F25L0218, 33F26A1264, 33F26A1290, 33F26A1313, 33F26B0291, 33F24C0728, 33F24C0729, 33F24E0699, 33F24G0596, 33F24H0057, 33F24J0350, 33F24J0458, 33F24K0615, 33F24M0126, 33F25A0338, 33F25B0039, 33F25B0131, 33F25D0192, 33F25D0281, 33F25E1109, 33F25F0496, 33F25J0764, 33F26B0054, 33F23M0173; AK-04020-C/60801902121549, 10801902193275, 10801902121551/33F24G0050, 33F24G0595, 33F24G0619, 33F24G0681, 33F24H0060, 33F24H0085, 33F24H0244, 33F24J0421, 33F24J0471, 33F24L0074, 33F24L0517, 33F24M0051, 33F24M0102, 33F24M0145,33F25A0354,33F25B0013, 33F25B0079, 33F25B0130, 33F25B0279, 33F25C0096, 33F25C0411, 33F25C0523, 33F25C0595, 33F25D0014, 33F25D0082, 33F25D0169, 33F25E0404, 33F25E1088, 33F25E1164, 33F25F0430, 33F25J1033, 33F25K0343, 33F25L0175, 33F25M0472, 33F26A0212, 33F26A1275, 33F26B0053, 33F26B0290, 33F23M0171; AK-04120/10801902190922, 10801902193275, 20801902121572/33F24A1254, 33F24B0432, 33F24C0731, 33F24D0440, 33F24E0701, 33F24H0444, 33F24J0006, 33F24K0623, 33F24L0035, 33F24M0127, 33F25A0129, 33F25B0057, 33F25B0328, 33F25E1096, 33F25F0405, 33F25F0522, 33F25G0511, 33F25J1067, 33F26C0419, 33F24C0789; AK-04122/20801902121572, 10801902193275, 10801902121582/33F24G0051, 33F24G0148, 33F24G0682, 33F24K0535, 33F24M0071, 33F25A0092, 33F25A0380, 33F25B0005, 33F25D0108, 33F25J0762, 33F25K0003, 33F24A1009; AK-04220/10801902190946, 10801902193275, 10801902121636/33F24C0733, 33F24E0703, 33F24G0117, 33F24G0223, 33F24G0683, 33F24H0246, 33F24H0414, 33F24J0009, 33F24J0447, 33F24M0003, 33F24M0086, 33F25C0085, 33F25D0171, 33F25G0065, 33F25J0059, 33F26C0392, 33F24A1257; ASK-04020-AH/10801902193275, 10801902114898/33F24L0219, 33F24L0398, 33F24L0950, 33F25B0174, 33F25C0436, 33F25D0332, 33F25D0648, 33F25E0848, 33F25H0647, 33F25J0350, 33F26C0572, 33F24G0403; ASK-04020-ATH/10801902193275, 10801902193237, 10801902205916/33F24J0553, 33F24K0167, 33F24L0777, 33F25C0133, 33F25C0982, 33F25E0964, 33F25G0106, 33F25G0670, 33F25H0063, 33F25H0727, 33F25L0242, 33F25L0452, 33F25M0947, 33F26B0583, 33F24D0856; ASK-04020-AU2/10801902205916, 10801902193275, 10801902117660/33F24E0645, 33F24F1044, 33F24K0365, 33F24L1020, 33F25A0230, 33F25C0225, 33F25D0333, 33F25E0523, 33F25E0849, 33F25H0474, 33F25J0199, 33F25L0120, 33F25M0208, 33F26A1419, 33F26B0449, 33F26C0030, 33F24A0814; ASK-04020-BHS/10801902193275, 30801902144578, 10801902211429/33F25A0231, 33F25D0589, 33F25E0850, 33F25F0095, 33F25G0320, 33F25J0200, 33F26A1514, 33R24D0228, 33S24C0678, 33S24C1077, 33F24D0277; ASK-04020-BIDB2/10801902193275/33F24K0168, 33F25A0508, 33F25C0134, 33F25C0835, 33F25E0121, 33F25G0107, 33F25H0065, 33F25H0728, 33F25J0669, 33F25K0399, 33F25L0429, 33F25M0929, 33F24J0365; ASK-04020-CCD1/10801902193275/33F24J0289, 33F24J0556, 33F24L0641, 33F25A0510, 33F25C0772, 33F25E0123, 33F25G0108, 33F25H0730, 33F25M0874, 33F24G0282; ASK-04020-CR/10801902193275, 10801902206814/33F24K0169, 33F24L0679, 33F25A0511, 33F25C0785, 33F25E0124, 33F25E0969, 33F25G0109, 33F25G0669, 33F25H0067, 33F25H0731, 33F25J0868, 33F25L0241, 33F25M0881, 33F26B0523, 33F24G0407; ASK-04020-EUH2/10801902193275, 10801902213379, 10801902193244/33F24J0290, 33F24J0557, 33F24L0753, 33F25A0512, 33F25C0930, 33F25E0125, 33F25H0068, 33F25J0869, 33F25M0894, 33F26B0236, 33F23H0888; ASK-04020-FAM1/10801902193275/ 33F24H0374, 33F24J0181, 33F24L0734, 33F25C0135, 33F25C0781, 33F25E0126, 33F25E0970, 33F25J0502, 33F24G0408; ASK-04020-FMC/10801902193275, 10801902121384/33F24J0558, 33F24K0171, 33F25A0513, 33F25C0773, 33F25E0127, 33F25E0971, 33F25H0069, 33F25J0870, 33F25L0388, 33F25M0892, 33F24A0828; ASK-04020-KSF2/10801902193275/33F25A0516, 33F25C0851, 33F25E0132, 33F25H0075, 33F25J0876, 33F25M0906, 33F24K0178; ASK-04020-LHC2/10801902193275, 10801902225525/33F24L0716, 33F25A0517, 33F25C0734, 33F25E0133, 33F25J0503, 33F25L0491, 33F25M0922, 33F26C0672; ASK-04020-LHC3/10801902193275, 10801902225525/33F24L0716, 33F25A0517, 33F25C0734, 33F25E0133, 33F25J0503, 33F25L0491, 33F25M0922, 33F26C0672, 33F24L0653; ASK-04020-LM/10801902193275/33F25B0690, 33F25E0977, 33F25H0076, 33F25J0877, 33F25L0422, 33F25M0925, 33F24G0417; ASK-04020-MCH1/10801902193275, 20801902117711/33F24L0920, 33F24A0380; ASK-04020-MIH1/10801902193275/33F24L0744, 33F25A0522, 33F25C0978, 33F25E0138, 33F25H0080, 33F25J0879, 33F26A0996, 33F25A0442; ASK-04020-NWMX/10801902193275/33F24K0186, 33F25J0882, 33F25L0363, 33F25M0872, 33F24G0423; ASK-04020-PHP/10801902193275, 10801902138498/33F24K0187, 33F25A0148, 33F25C0401, 33F25D0283, 33F25E1145, 33F25J1027, 33F24C0164; ASK-04020-RIHM/10801902193275/33F24L0243, 33F24L1034, 33F25B0177, 33F25C0256, 33F25D0462, 33F25E0525, 33F25E0773, 33F25G0317, 33F25H0645, 33F25J0351, 33F26A1408, 33F24M0095; ASK-04020-RMC1/10801902193275/33F25J0509, 33F25L0464, 33F24L0747; ASK-04020-RU/10801902193275/33F25A0524, 33F25C0807, 33F25E0143, 33F25G0112, 33F25J0510, 33F25M0863, 33F24G0427; ASK-04020-SE/10801902193275, 10801902213263, 10801902138757/33F24L0611, 33F25A0525, 33F25C0849, 33F25E0144, 33F25E0984, 33F25J0511, 33F26B0999, 33F24E0433; ASK-04020-SHM/10801902193275/33F24G0428, 33F24J0576, 33F24K0190, 33F24L0684, 33F25A0526, 33F25C0971, 33F25E0145, 33F25G0113, 33F25J0512, 33F25L0378, 33F25M0883, 33F25C0143; ASK-04020-SRMC1/10801902193275, 10801902117837/33F24J0296, 33F24K0192, 33F24L0710, 33F25C0144, 33F25C0820, 33F25E0146, 33F25H0086, 33F25J0884, 33F25M0842, 33F24A0868; ASK-04020-UCL1/10801902193275, 10801902144550/33F24K0412, 33F24L1081, 33F25A0233, 33F25C0257, 33F25D0393, 33F25E0774, 33F25G0360, 33F25J0201, 33F26B0160, 33F24G0178; ASK-04020-UMI/10801902193275, 10801902145571/33F24L1123, 33F24E0726; ASK-04020-UN/10801902145571, 10801902193275, 60801902117849/33F24K0021, 33F24L0533, 33F24M0053, 33F24M0107, 33F25A0089, 33F25B0016, 33F25B0092, 33F25B0314, 33F25D0015, 33F25D0113, 33F25D0172, 33F25E1146, 33F25H0797, 33F25K0230, 33F26B0090, 33F26B0262, 33F24A0373; ASK-04020-UNC/60801902117849, 10801902193275, 10801902143782/33F24A1035, 33F24B0270, 33F24C0170, 33F24G0432, 33F24J0297, 33F24J0577, 33F24L0799, 33F25A0527, 33F25C0145, 33F25C0994, 33F25E0147, 33F25H0088, 33F25J0513, 33F25L0359, 33F25M0868, 33F26A0993, 33F26B0975, 33F24F0461; ASK-04020-UNC1/10801902193275, 10801902143782, 10801902117851/33F24G0286, 33F24J0298, 33F24K0194, 33F24L0806, 33F25C0146, 33F25E0148, 33F25H0089, 33F25J0514, 33F25L0469, 33F25M0959, 33F26C0599, 33F24A0255; ASK-04220-PSU/10801902193275/33F25A0152, 33F25H0737, 33F24K0495; ASK-04220-UCL1/10801902193275, 10801902159127, 10801902143805/33F24L0290, 33F25A0206, 33F25C0226, 33F25D0463, 33F25E0669, 33F25G0351, 33F25H0428, 33F25J0352, 33F26B0153, 33F24F0619; NA-04020-S1A/10801902193275, 10801902139396/33F25A0600, 33F25C0195, 33F25C0786, 33F25E0270, 33F25E1050, 33F25G0152, 33F25H0177, 33F25H0759, 33F25J0633, 33F25K0404, 33F25L0472, 33F25M0962, 33F26B0595, 33F24J0683; ASK-04550-JMC1/10801902193275, 10801902130836/33F25C0837, 33F25E0175, 33F25E0997, 33F25L0146, 33F24F0685; ASK-04001-BW2/10801902193275, 10801902221602/33F25A0500, 33F25E0110, 33F25H0057, 33F25J0496, 33F25L0360, 33F26A0994, 33S23M0157, 33F25A0226; ASK-04001-WUH1/10801902193275, 10801902220834, 10801902119268/33F24J0549, 33F24K0162, 33F24L0685, 33F25H0061, 33F25J0864, 33F26B0683, 33F26B1021, 33F24A0078; ASK-04510-HUM/10801902115048/33F24C0956, 33F24D0699, 33F24E0647, 33F24F0911, 33F24L0885

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 7 of 35

Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4; PSI/CVC KIT: 9 FR/7 FR X 6IN (16CM)/ASK-09903-AMC1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-CMC1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU4; PSI KIT: 9 FR X 4 1/8 IN (10CM)/ASK-09903-PCMH1; PSI KIT: 8.5 FR X 10 CM/CDC-09803-1A; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL3; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-PHP2; MULTI LUMEN/PSI KIT/ASK-11142-NSU; MULTI-LUMEN/PSI KIT/AK-21242-X; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-DMC; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-GMC1; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-HF5; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDT; 2L MAC KIT: 9 FR DISTAL X 4IN (10 CM)/ASK-21142-UCL1; 2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-SL1; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMH; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UN1; MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB/CDC-21142-XCN1A; MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB/CDC-21142-XN1A; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-XCN1A; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-XN1A; 2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-CO1; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH3; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-OHSU3; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-SG2; MULTILUMEN/MAC KIT: 9 FR X 4 IN (10 CM)/ASK-21142-UOI1; 2 LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-WHC2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-BID1; AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-BSWH2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-DU1; MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-PCMH1; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UCH2; AGB MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UHC2; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-BSWH2; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-HHC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-MCY1; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-UPM1; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29804-VCU; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-MCY1; PSI KIT: 9 FR/ASK-29903-MHI; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-OHU4; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-UCH2; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UCL1; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UHC4; PSI KIT: 9FR X 4IN (10 CM) ANTIMICROBIAL/ASK-29903-UPM1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29907-LGH; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-X1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-XCN1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-XN1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-AHH; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XN1A; PSI ACCESS TRAY/ASK-04001-MM2; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-GMC; MULTI LUMEN/PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU3

Z-2369-2026

Recall number: Z-2369-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 348,684

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): ASK-09701-UMH/10801902193275, 10801902139365, 10801902143874/33F24M0171, 33F25A0444, 33F25G0008, 33F25K0039, 33F25L0133, 33F26B0369, 33F23K0811; ASK-09803-OSU4/10801902212075, 10801902193275/33F24F0994, 33F24K0428, 33F25B0183, 33F25D0761; ASK-09903-AMC1/1080190219327, 10801902161830, 10801902136678/33F25A0437, 33F25E0024, 33F25G0690, 33F25L0142, 33F26C0117, 33F24B0612; ASK-09903-CMC1/10801902136678, 10801902193275/33F24D0050, 33F24D0965, 33F24F0130, 33F24J0321, 33F24J0627, 33F24L0585, 33F25A0110, 33F25C0176, 33F25C0588, 33F25E0212, 33F25E1020, 33F25F0324, 33F25G0753, 33F25L0208, 33F26A0396, 33F26A1255, 33F25E0716; ASK-09903-OSU4/10801902212006, 10801902193275/33F24G0022, 33F24L0298, 33F25D0762; ASK-09903-PCMH1/10801902193275, 20801902115205/33F25L0139, 33F26B0136, 33F24H0108; CDC-09803-1A/50801902116715, 10801902193275, 60801902116729/33F24D0892, 33F24F0766, 33F24L0274, 33F25B0147, 33F25C0497, 33F25C0498, 33F25D0553, 33F25E0647, 33F25F0209, 33F25H0574, 33F25L0121, 33F25M0410, 33F24D0504; ASK-09903-ECL3/10801902193275/33F25G0241, 33F25H0530, 33F25J0357, 33F26A0015; ASK-11242-PHP2/10801902193275, 10801902196436/33F24J0117, 33F24K0727, 33F25A0009, 33F25E0003, 33F25F0359, 33F25K0040, 33F25L0132, 33F26B0223, 33F26D0016, 33F24K0544; ASK-11142-NSU/10801902182545, 10801902193275/33F24E0326, 33F24K0354, 33F24L0244, 33F24L0300, 33F25B0189, 33F25C0228, 33F25D0467, 33F25E0591, 33F25G0272, 33F25G0405, 33F25H0629, 33F25J0363, 33F26A1572, 33F26B0816, 33F24L0840; AK-21242-X/10801902193275, 30801902122262, 80801902123127/33F24G0358, 33F24J0522, 33F24K0124, 33F24L0749, 33F25B0683, 33F25E0073, 33F25J0479, 33F25L0443, 33F26C0301, 33F24D0371; ASK-21142-DMC/10801902193275, 10801902218930, 10801902206685/33F25B0242, 33F25M0671, 33F26A0237, 33F26B0946, 33F24D0718; ASK-21142-GMC1/10801902193275, 10801902200492/33F25B0642, 33F25E0719, 33F25H0582, 33F25M0147, 33F26C0335, 33F24F0098; ASK-21142-HF5/10801902200492, 10801902193275, 10801902200492/33F24F0921, 33F24K0350, 33F24L0245, 33F25A0168, 33F25C0272, 33F25D0344, 33F25F0103, 33F25G0282, 33F25H0614, 33F25J0371, 33F26A1525, 33F26C0040, 33F24L0309; ASK-21142-LMDT/10801902193275, 10801902220728/33F25A0041, 33F25B0381, 33F25D0346, 33F25F0172, 33F25K0416, 33F25M0343, 33F26B0189, 33F26C0139, 33F25K0206; ASK-21142-UCL1/10801902193275/33F25E0541, 33F25G0391, 33F25J0102, 33F25J0373, 33F25M0235, 33F26A1375, 33F24H0098; ASK-21142-UPMC2/10801902159479, 10801902193275, 10801902225365/33F24F0879, 33F24J0161, 33F24L0310, 33F24L1023, 33F25C0276, 33F25E0780, 33F25G0348, 33F25J0209, 33F26A1371, 33F26A1547, 33R25G0348, 33F26C0490; ASK-21242-SL1/10801902193275/33F26A1347, 33F25E0314; ASK-21242-UMH/10801902129502, 10801902193275, 10801902156348/33F24E0637, 33F24F0895, 33F24L0317, 33F25B0197, 33F25C0280, 33F25D0478, 33F25F0178, 33F25H0564, 33F25L0106, 33F26A1517, 33F24F0618; ASK-21242-UN1/10801902193275, 10801902156348/33F24H0146, 33F25A0438, 33F25D0032, 33F25E0315, 33F25F0236, 33F25H0778, 33F25K0044, 33F26A0252, 33F26B0219, 33F26C0048, 33F25C0816; CDC-21142-XCN1A/10801902196498, 10801902193275/33F24E0226, 33F24E0242, 33F24E0254, 33F24F0250, 33F24G0203, 33F24H0356, 33F24H0391, 33F24J0220, 33F24L0078, 33F24M0018, 33F24M0054, 33F24M0206, 33F25A0130, 33F25A0385, 33F25B0068, 33F25B0340, 33F25C0076, 33F25C0510, 33F25D0697, 33F25D0733, 33F25E1092, 33F25E1101, 33F25F0435, 33F25G0027, 33F25H0334, 33F25H0814, 33F25J1006, 33F25K0310, 33F25L0090, 33F25L0277, 33F26A1615, 33F26A1622, 33F26A1623, 33F26A1645, 33F25B0528; CDC-21142-XN1A/10801902193275, 10801902196504, 50801902116821/33F25D0441, 33F25E0816, 33F25F0210, 33F25J0418, 33F26B0438, 33F26B0809, 33F26C0018, 33F24D0429; CDC-21242-XCN1A/10801902196511, 10801902193275, 10801902196511/33F24D0427, 33F24D0493, 33F24D0502, 33F24E0257, 33F24E0833, 33F24G0147, 33F24G0162, 33F24G0202, 33F24G0249, 33F24G0620, 33F24H0067, 33F24H0330, 33F24H0355, 33F24H0390, 33F24H0423, 33F24H0449, 33F24J0252, 33F24K0013, 33F24K0041, 33F24K0629, 33F24L0158, 33F24M0056, 33F24M0066, 33F24M0091, 33F25A0132, 33F25A0373, 33F25B0028, 33F25B0097, 33F25B0135, 33F25C0217, 33F25C0529, 33F25C0692, 33F25D0690,33F25D0692, 33F25D0698, 33F25D0707, 33F25D0721, 33F25D0734, 33F25D0754, 33F25E0415, 33F25E1102, 33F25E1123, 33F25E1152, 33F25F0030, 33F25F0039, 33F25F0484, 33F25F0525, 33F25H0335, 33F25H0872, 33F25J0747, 33F25J0774, 33F25K0292, 33F25K0353, 33F25L0092, 33F25L0236, 33F25L0298, 33F26A1617, 33F26A1626, 33F26A1632, 33F26A1635, 33F26B0621, 33F26B0622, 33F26B1039, 33F26D0229, 33F26D0230, 33X25J0002, 33F24H0395; CDC-21242-XN1A/10801902193275, 10801902196528, 20801902123484/33F25A0378, 33F25B0029, 33F25B0098, 33F25B0341, 33F25C0420, 33F25C0530, 33F25E1093, 33F25E1124, 33F25H0286, 33F25H0362, 33F25J0775, 33F25J1040, 33F26A1618, 33F26A1627, 33F26C0453, 33F26C0881, 33X25J0001, 33F24F0996; ASK-21142-CO1/10801902214291, 10801902193275/33F24F0767, 33F24K0423, 33F25B0548, 33F25D0266, 33F25F0170, 33F25H0592, 33F25K0136, 33F26A1450, 33F26C0489, 33F24J0113; ASK-21142-FH3/10801902206685, 10801902193275/33F24E0615, 33F24F0988, 33F24K0455, 33F24L0308, 33F24L0896, 33F25A0244, 33F25B0549, 33F25E0539, 33F25F0171, 33F25G0254, 33F25H0607, 33F26A1574; ASK-21142-OHSU3/10801902193275, 10801902188899, 10801902129953/33F25E1194, 33F25G0692, 33F25K0041, 33F25K0422, 33F26B0907, 33F24F0049; ASK-21142-SG2/10801902193275/33F25B0550, 33F25C0274, 33F25E0540, 33F25F0174, 33F25H0533, 33F25J0208, 33F26B0198, 33F26B0786, 33F25G0695; ASK-21142-UOI1/10801902193275, 10801902158878, 10801902159479/33F24J0014, 33F25A0013, 33F25B0425, 33F25E0012, 33F25G0553, 33F25H0773, 33F25K0042, 33F25L0259, 33F26A0236, 33F26C0115, 33F24D0800; ASK-21142-WHC2/10801902193275, 10801902134964/33F25B0643, 33F25D0473, 33F25E0857, 33F25F0114, 33F25J0210, 33F26C0338, 33F24H0148; ASK-21242-BID1/10801902193275, 10801902219135, 10801902220339/33F24L1014, 33F25B0644, 33F25E0594, 33F25F0091, 33F25F0346, 33F25H0454, 33F25J0211, 33F26C0376, 33F24F0067; ASK-21242-BSWH2/10801902220339, 10801902193275, 10801902160987/33F24F0965, 33F24K0451, 33F24L0311, 33F25A0298,33F25B0645, 33F25D0347, 33F25E0542, 33F25E0858, 33F25G0206, 33F25H0515, 33F25J0212, 33F25K0094, 33F25M0326, 33F26A1445, 33F26C0152, 33F24D0321; ASK-21242-DU1/10801902160987, 10801902193275, 10801902118407/33F24D0797, 33F24F0859, 33F24J0149, 33F24L1085, 33F25B0440, 33F25C0277, 33F25D0400, 33F25E0859, 33F25H0557, 33F25J0213, 33F25K0095, 33F24E0539; ASK-21242-PCMH1/10801902160987, 10801902193275, 10801902118407/33F24D0797, 33F24F0859, 33F24J0149, 33F24L1085, 33F25B0440, 33F25C0277, 33F25D0400, 33F25E0859, 33F25H0557, 33F25J0213, 33F25K0095, 33F24E0539; ASK-21242-UCH2/10801902219036, 10801902193275/33F24F0756, 33F24L1051, 33F25C0343, 33F25D0474, 33F25F0177, 33F25H0586, 33F25J0375, 33F26A1495, 33F26C0180, 33F26C0502, 33F25D0224; ASK-21242-UHC2/10801902193275, 10801902159639, 10801902114065/33F25D0349, 33F25F0115, 33F25G0349, 33F25H0634, 33F25J0377, 33F26C0173, 33F24D0662; ASK-29803-BSWH2/10801902220346, 10801902193275/33F24F1006, 33F24K0461, 33F24L0407, 33F25B0472, 33F25B0648, 33F25C0344, 33F25F0092, 33F25F0142, 33F25H0514, 33F25J0382, 33F25M0186, 33F26A1428, 33F26B0834, 33F26A0014; ASK-29803-HHC/10801902193275, 10801902211443/33F25A0213, 33F25B0442, 33F25F0181, 33F25G0247, 33F25J0152, 33F26B0174, 33F25E0548; ASK-29803-MCY1/10801902193275/33F24H0203, 33F24K0386, 33F24L0409, 33F25B0649, 33F25E0720, 33F25G0200, 33F25E0549; ASK-29803-UPM1/10801902193275, 10801902225136/33F24L0227, 33F24L0876, 33F25C0284, 33F25E0782, 33F25G0392, 33F25K0097, 33F25L0117, 33F26A1584, 33F26C0510; ASK-29804-VCU/10801902193275, 10801902112986/33F25E0551, 33F25F0360, 33F26B0225, 33F24L0889; ASK-29903-MCY1/10801902193275, 10801902221039, 10801902217087/33F24L0322, 33F25C0348, 33F25D0481, 33F25F0182, 33F25G0199, 33F25J0264, 33F26A1571, 33F26B0869, 33F24D0590; ASK-29903-MHI/10801902217087, 10801902193275/33F24F0808, 33F24L0831, 33F25B0474, 33F25E0555, 33F25H0458, 33F25J0265, 33F26C0341, 33F25F0008; ASK-29903-OHU4/10801902193275/33F25E0449, 33F25C0289; ASK-29903-UCH2/10801902193275/33F24K0489, 33F24L0410, 33F24L1024, 33F25C0350, 33F25F0183, 33F25H0587, 33F26A1458, 33F25H0438; ASK-29903-UCL1/10801902193275, 10801902144512/33F25J0385, 33F26B0713, 33F25B0200; ASK-29903-UHC4/10801902193275, 10801902159622/33F25F0184, 33F25H0470, 33F25J0154, 33F26B0123, 33F26C0025, 33F24H0118; ASK-29903-UPM1/10801902193275, 10801902159530, 10801902225174/33F24L0326, 33F25B0555, 33F25E0674, 33F25F0185, 33F25G0263, 33F25G0347, 33F25J0217, 33F25M0113, 33F26B0178, 33F26C0511; ASK-29907-LGH/10801902193275/33F25A0008, 33F25D0033, 33F25G0684, 33F25L0260, 33F25G0459; CDC-29803-1A/50801902117019, 10801902193275/33F24F0800, 33F24J0177, 33F24L0119, 33F24L1142, 33F25B0678, 33F25D0509, 33F25E0750, 33F25G0277, 33F25G0388, 33F25J0181, 33F26A1385, 33F26B0435, 33F25E0796; CDC-29903-1A/60801902117030, 10801902193275/33F24F0742, 33F24K0372, 33F24L0121, 33F24L1146, 33F25A0289, 33F25B0531, 33F25F0086, 33F25G0177, 33F25G0319, 33F25H0575, 33F25J0253 ,33F25M0106, 33F26A1491, 33F25J0671; CDC-29903-X1A/10801902193275, 20801902117049, 10801902193190/33F25J0679, 33F25J0726, 33F25K0187, 33F26A1553, 33F26C0352, 36F25B0022, 36F25G0002, 36F25G0019, 36F25G0025, 36F25H0007, 33F24E0229; CDC-29903-XCN1A/10801902193190, 10801902193275/33F24F0025, 33F24F0160, 33F24G0207, 33F24G0248, 33F24H0075, 33F24H0432, 33F24J0254, 33F24K0042, 33F24K0692, 33F24M0076, 33F24M0135, 33F25A0133, 33F25B0020, 33F25B0069, 33F25B0119, 33F25B0318, 33F25C0512, 33F25D0691, 33F25D0699, 33F25D0723, 33F25D0755, 33F25E1125, 33F25F0040, 33F25F0402, 33F25G0488, 33F25J0656, 33F25J0777, 33F25K0312, 33F25L0012, 33F25L0315, 33F25M0045, 33F26A1629, 33F26B0527, 33F26B0926, 33F26C0073, 33F26C0086, 33F26C0100, 33F26C0550, 33F25A0314; CDC-29903-XN1A/10801902193275, 10801902193206/33F25B0532, 33F25D0511, 33F25E0701, 33F25E0894, 33F25H0423, 33F25H0623, 33F25J0326, 33F26A1475, 33F26B0734, 33F26C0019, 33F25C0701; ASK-29903-AHH/10801902193275/33F25B0553, 33F25F0143, 33F25G0384, 33F25H0489, 33F25M0239, 33F24L0166; CDC-29803-XN1A/10801902193275, 10801902193121, 60801902117030/33F25D0510, 33F25E0700, 33F25E0893, 33F25G0337, 33F25J0252, 33F25M0400, 33F26B0152, 33F26B0733, 33F26B0820, 33F26C0009, 33F26C0582, 33F24D0888; ASK-04001-MM2/10801902193275, 10801902160086, 10801902114881/33F25B0428, 33F26B0220, 33F24D0538; ASK-21142-GMC/10801902189674/33F24K0062, 33F24K0670, 33F24M0044, 33F25A0105; ASK-21242-OSU3/10801902211986/33F24F0720, 33F24K0338, 33F24L0312;

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 8 of 35

Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS AGBA PICC/DELTA KIT: 1L 4.5 FR X 55 CM/ASK-45541-MHBV PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS/ASK-45552-RH AGBA PICC NaviCurve: 2L 5.5FR x 55CM BP/DLX-45552-CURVB AGBA PICC NaviCurve: 2L 5.5FR x 55CM TCG/DLX-45552-CURVC AGBA PICC: 2L 5.5FR x 55CM w Biopatch/DLX-45552-HPKB AGBA PICC NaviCurve: 3L 6FR x 55CM BP/DLX-45563-CURVB PI PICC KIT: 4 FR X 50 CM/ASK-35041-NH PI PICC KIT: 2-L 5 FR X 50 CM/ASK-35052-NH PI PICC G4 Stylet: 1L 4FR x 55CM w CHG/DLX-35541-VPSC PI PICC NaviCurve: 2L 5FR x 55CM w BP/DLX-35552-CURVB PI PICC NaviCurve: 3L 6FR x 55CM w BP/DLX-35563-CURVB PI PICC G4 Stylet: 3L 6FR x 55CM w BP/DLX-35563-VPSB AGBA PI PICC KIT: 2L 5.5 FR X 55CM/CDC-45552-HPK1A PI AGBA PICC KIT: 3-L 6 FR X 55 CM/CDC-45563-HPK1A PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI1 PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-VFH1 PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI1 PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-VFH1 PI AGBA PICC KIT: 3L 6 FR X 55 CM W/VPS/ASK-45563-UWH1 AGBA PICC NaviCurve: 1L 4.5FR x 55CM BP/DLX-45541-CURVB AGBA PICC NaviCurve: 1L 4.5FR x 55CM TCG/DLX-45541-CURVC AGBA PICC G4 Stylet: 1L 4.5FR x 55CM TCG/DLX-45541-VPSC AGBA PICC G4 Stylet: 2L 5.5FR x 55CM BP/DLX-45552-VPSB AGBA PICC G4 Stylet: 2L 5.5FR x 55CM TCG/DLX-45552-VPSC PI PICC:1L 4FR X 50CM PRELOAD VPS STYLET/CDC-35041-VPS PICC KIT: 3 FR X 55 CM/CDC-05531-PK1A

Z-2370-2026

Recall number: Z-2370-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 37,738

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): ASK-44063-NS/10801902193275/33F25F0100; ASK-45052-NS/10801902193275/33F24L0864 ASK-45541-MHBV/10801902193275, 10801902167696/33F25D0410, 33F26C0012, 33S24A0690, 33F25B0574; ASK-45552-RH/10801902193275/33F25B0575, 33F25D0361, 33F25F0197, 33F25K0373, 33F25A0082; DLX-45552-CURVB/10801902193275, 10801902208702/33F25E0506, 33F25E0833, 33F26C0038, 33S24B0518, 33F24L0982; DLX-45552-CURVC/10801902193275, 10801902208733/33F25B0386, 33F25D0381, 33F25D0624, 33F25E0765, 33F25F0225, 33F25H0602, 33F26C0182, 33F25B0390; DLX-45552-HPKB/10801902193275, 10801902208825, 10801902208856/33F25D0454, 33F25D0677, 33F25E0834, 33F25J0446, 33F25M0172, 33F26B0867, 33S24A0586, 33S24A1370, 33F24F0097; DLX-45563-CURVB/10801902193275/33F25C0339, 33F25E0836, 33F25A0321; ASK-35041-NH/10801902221077, 10801902193275/33F26B0140 33F25G0460; ASK-35052-NH/10801902193275/33F25H0412, 33F24L1080; DLX-35541-VPSC/10801902193275/33F25C0449, 33F25D0245, 33F25H0501, 33F24L1148; DLX-35552-CURVB/10801902193275, 10801902208764/33F25C0214, 33F25E0511 ,33F25E0832 ,33F26C0120 33F26C0732, 33F25C0373; DLX-35563-CURVB/10801902193275, 10801902208771/33F25C0337, 33F26B0155, 33F25D0453; DLX-35563-VPSB/10801902193275/33F25C0395; CDC-45552-HPK1A/10801902193275, 10801902188462/33F25D0067, 33F25D0243, 33F25E0452, 33F25E0658, 33F25E0829, 33F26B0891, 33F26C0202, 33S23K0168, 33S24A0419, 33S24A0523, 33S24A1387, 33F25K0317; CDC-45563-HPK1A/10801902193275, 10801902188479/33F25G0283, 33F25H0626, 33S24A0543, 33F24D0497; ASK-45541-UOI1/10801902193275, 10801902221664/33F25H0411, 33F25J0399, 33S24A1368, 33F26A0226; ASK-45541-VFH1/10801902193275, 10801902218886/33F25B0655, 33F25E0573, 33F25G0210, 33F26A1533, 33F26B0841, 33F25G0584; ASK-45552-UOI1/10801902193275/33F26A0227; ASK-45552-VFH1/10801902193275/33F25D0362, 33F25E0866, 33F25J0226, 33F25M0180, 33F26A1455, 33F25H0408; ASK-45563-UWH1/10801902193275/33F25D0660, 33F25J0227, 33F24K0066; DLX-45541-CURVB/10801902193275/33F25B0385, 33F25D0250, 33F25E0760, 33F25J0336, 33F25K0194, 33F24L1115; DLX-45541-CURVC/10801902193275/33F25B0507, 33F25C0216, 33F25E0761, 33F25F0223, 33F25G0362, 33F25J0337, 33F25E0762; DLX-45541-VPSC/10801902193275, 10801902208610/33F24L0390, 33F24L1130, 33F25C0247, 33F25D0251, 33F25D0380, 33F25D0623, 33F25E0764, 33F25E0900, 33F25F0224, 33F25H0604, 33F25J0445, 33F26A1541, 33F26B0460, 33F26C0220, 33F26C0717, 33F25B0387; DLX-45552-VPSB/10801902193275/33F25C0249, 33F25D0253, 33F25D0314, 33F25D0382, 33F24L0392; DLX-45552-VPSC/10801902193275, 10801902208634/33F24L0939, 33F25B0508, 33F25D0254, 33F25D0315, 33F25D0383,33F25D0626, 33F25E0581, 33F25E0709, 33F25E0835, 33F25J0129, 33F25J0257, 33F25M0167, 33F26B0712, 33F26B0937, 33F25B0388; CDC-35041-VPS/10801902186741, 10801902193275/33X25K0001, 33F25E0425; CDC-05531-PK1A/10801902193275, 60801902123420/33F25C0641, 33F25D0435, 33F25E0646, 33F25J0416, 33F26B0711, 33F25D0765

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 9 of 35

Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EPIDURAL CATHETERIZATION KIT/AK-05502; EPIDURAL CATHETERIZATION KIT/AK-05502D; EPIDURAL CATHETERIZATION KIT/AK-05503; EPIDURAL CATHETERIZATION KIT/AK-05503-L; SPINAL ANES/EPIDURAL CATH KIT/AK-05560; SPINAL ANES/EPIDURAL CATH KIT/ASK-02520-SBMC1; EPIDURAL CATHETERIZATION KIT/ASK-05400-BW1; EPIDURAL CATHETERIZATION KIT/ASK-05400-GH; SPINAL ANES/EPIDURAL CATH KIT/ASK-05401-LMC; EPIDURAL CATHETERIZATION KIT/ASK-05401-NM; SPINAL ANES/EPIDURAL CATH KIT/ASK-05500-BID1; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-JHH1; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-MCV1; EPIDURAL CATHETER KIT: 19GA X 90CM ASK-05500-MVH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05500-UMC; 19 GA X 35.5 IN EPIDURAL CATHETER KIT/ASK-05502-MLH; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-JMH1; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-MKD2; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-OM1; EPIDURAL CATHETERIZATION KIT/ASK-17019-SM; EPIDURAL CATHETERIZATION KIT/BP-05501; EPIDURAL CATHETERIZATION KIT/CK-05401; EPIDURAL CATHETERIZATION KIT/HS-05501; EPIDURAL CATHETERIZATION KIT/MM-05501; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TK; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TKD; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TKL; EPIDURAL CATHETERIZATION KIT/MSO-05401-JMH; EPIDURAL CATHETERIZATION KIT/NM-05401; EPIDURAL CATHETERIZATION KIT/SJ-05501; EPIDURAL CATHETERIZATION KIT/SM-05401; EPIDURAL CATHETER KIT: 19 GA X 90 CM/TM-05401; EPIDURAL CATHETERIZATION KIT/TM-05502; SPINAL ANES/EPIDURAL CATH KIT/UI-05502; SPINAL ANES/EPIDURAL CATH KIT: 19 GA/ASK-05400-SHM; EPIDURAL CATH KIT: 19 GA/ASK-05400-UOM; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05500-MR; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-TM; EPIDURAL CATHETERIZATION KIT/ASK-05501-BHL1; EPIDURAL CATHETERIZATION KIT/ASK-05501-GH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-SM; EPIDURAL CATHETERIZATION KIT/ASK-05502-BSM; EPIDURAL CATHETERIZATION KIT/ASK-05502-MGH1; EPIDURAL CATHETERIZATION KIT/ASK-05503-BWB1; EPIDURAL CATHETERIZATION KIT/ASK-05503-HMH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05503-SPH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05503-UPM1; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-UCI2; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-17019-UMP; EPIDURAL CATHETERIZATION KIT/MH-05503-1; EPIDURAL CATHETERIZATION KIT/ASK-05401-VB2; Epidural Catheterization Kit: 19GA/ASK-05500-SC1; Epidural Catheterization Kit: 19GA/ASK-05500-SC3; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-AFH1; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-BMC; EPIDURAL CATHETERIZATION KIT/ASK-05502-NY; EPIDURAL CATHETERIZATION KIT/ASK-17019-RMH

Z-2371-2026

Recall number: Z-2371-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 1,525,831

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): ASK-05502-VM1/10801902210217, 10801902209938/33F25C0168, 33F25C0880, 33F25E0202, 33F25G0134, 33F25H0126, 33F26C0297, 33F24C0216; AK-05501/)10801902210217, 10801902209501, 10801902209518/33F24E0057, 33F24E0058, 33F24J0496, 33F24K0094, 33F24L0564, 33F25A0460, 33F25A0617, 33F25C0728,33F25E0043, 33F25E0913, 33F25G0081, 33F25H0015, 33F25J0465, 33F25J0822, 33F25K0254, 33F25L0376, 33F26C0300, 33F24B0119; AK-05502/10801902209518, 10801902210217, 10801902209525/33F24C0015, 33F24G0581, 33F24G0582, 33F24G0583, 33F24J0497, 33F24J0678, 33F24J0679, 33F24J0680, 33F24J0681, 33F24K0095, 33F24K0310, 33F24L0580, 33F24L0624, 33F24L0628, 33F24L0630, 33F24L0757, 33F24L0785, 33F25A0461, 33F25A0618, 33F25A0619, 33F25A0620, 33F25C0103, 33F25C0724, 33F25C0725, 33F25C0741, 33F25C0791, 33F25E0044, 33F25E0291, 33F25E0292, 33F25E0293, 33F25E0914, 33F25E1067, 33F25G0082, 33F25G0159, 33F25H0016, 33F25H0197, 33F25H0198, 33F25H0199, 33F25J0466, 33F25J0643, 33F25J0790, 33F25J0805, 33F25J0806, 33F25J0807, 33F25J0808, 33F25K0024, 33F25K0252, 33F25K0358, 33F25K0359, 33F25L0099, 33F25L0266, 33F25L0267, 33F25M0970, 33F25M0978, 33F26A1100, 33F24C0096; AK-05502D/10801902210217, 10801902209532/33F24G0331, 33F24J0498, 33F24K0096, 33F24L0713, 33F25A0462, 33F25C0745, 33F25E0045, 33F25H0017, 33F25J0467, 33F25L0366, 33F24C0017; AK-05503/10801902210217, 10801902209549/33F24J0277, 33F24J0499, 33F24K0097, 33F24L0674, 33F25A0463, 33F25C0949, 33F25E0046, 33F25E0915, 33F25H0018, 33F25J0823, 33F25L0406, 33F25M0912, 33F24C0018; AK-05503-L/10801902209549, 10801902210217, 10801902209549/33F24C0019, 33F24E0066, 33F24J0682, 33F24K0098, 33F24L0613, 33F24L0758, 33F25A0464, 33F25C0104, 33F25C0731, 33F25C0793, 33F25E0047, 33F25E0916, 33F25G0083, 33F25H0019, 33F25H0200, 33F25J0791, 33F25J0809, 33F25K0026, 33F25K0253, 33F25L0057, 33F25L0352, 33F25M0861, 33F26A0989, 33F24J0278; AK-05560/10801902210217, 10801902209556, 30801902121722/33F24J0501, 33F24K0099, 33F24L0552, 33F25A0145, 33F25A0465, 33F25C0743, 33F25E0048, 33F25E0917, 33F25G0084, 33F25H0020, 33F25J0737, 33F25J0824, 33F25M0895, 33F26B0538, 33F26C0592, 33F24A0812; ASK-02520-SBMC1/10801902209570, 10801902210217, 10801902193275/33F24D0103, 33F24F0275, 33F24G0396, 33F25A0137; ASK-05400-BW1/10801902209617, 10801902209631/33F24D0153, 33F24E0474, 33F24G0461, 33F24J0307, 33F24L0556, 33F25B0246, 33F25C0729, 33F25E0178, 33F25G0121, 33F25J0899, 33F25L0042, 33F25L0450, 33F24C0196; ASK-05400-GH/10801902209631, 10801902210217, 10801902202199/33F24D0154, 33F24E0480, 33F24G0292, 33F24J0310, 33F24J0600, 33F24L0597, 33F25A0153, 33F25C0161, 33F25C0754, 33F25E0181, 33F25G0123, 33F25J0532, 33F25L0391, 33F25M0897, 33F24D0155; ASK-05401-LMC/10801902210217, 10801902209662/33F24J0603, 33F25F0240, 33F25G0754, 33F25J0534, 33F24D0031; ASK-05401-NM/10801902210217/33F24E0104, 33F24G0295, 33F24J0311, 33F24J0604, 33F24K0223, 33F24L0559, 33F25A0548, 33F25C0840, 33F25E0184, 33F25G0125, 33F25H0113, 33F25J0535, 33F25L0024, 33F25L0361, 33F24E0027; ASK-05500-BID1/10801902210217/33F24E0490, 33F24G0297, 33F24H0488, 33F24J0607, 33F24L0594, 33F25A0551, 33F25C0823, 33F25E0187, 33F25G0127, 33F25J0536, 33F25L0438, 33F24K0228; ASK-05500-JHH1/10801902210217, 10801902209716, 10801902209723/33F24L0572, 33F25B0379, 33F25D0215, 33F25E0190, 33F25G0129, 33F25H0744, 33F25J0538, 33F25K0407, 33F25M0955, 33S24L0572, 33F24C0203; ASK-05500-MCV1/10801902210217/33F24E0494, 33F24E0495, 33F24G0470, 33F24J0611, 33F24K0229, 33F24L0707, 33F25A0554, 33F25C0784, 33F25E0191, 33F25E1005, 33F25G0761, 33F25H0115, 33F24E0496; ASK-05500-MVH/10801902209730, 10801902210217/33F24D0380, 33F24E0498, 33F24G0472, 33F24L0681; ASK-05500-UMC/10801902209754, 10801902210217/33F24D0382, 33F24J0316, 33F24K0233, 33F24L0085, 33F24L0772, 33F25C0166, 33F25C0737, 33F25E0196, 33F25E0317, 33F25E1008, 33F25H0120, 33F25J0540, 33F25L0397, 33F25M0904, 33F24E0502; ASK-05502-MLH/10801902210217/33F24J0618, 33F24K0239, 33F24L0555, 33F25A0562, 33F25C0996, 33F25E0201, 33F25H0125, 33F25J0544, 33F25L0440, 33F26B0977, 33F24L0583; ASK-05560-JMH1/10801902210217, 10801902209983/33F24G0483, 33F24L0773, 33F25A0566, 33F25C0894, 33F25E1014, 33F25H0130, 33F25J0548, 33F24E0519; ASK-05560-MKD2/10801902193275, 10801902210217/33F24K0246, 33F25G0468, 33F24J0476; ASK-05560-OM1/10801902210217, 10801902210002/33F24K0550, 33F25A0155, 33F25C0171, 33F25F0383, 33F25G0560, 33F25H0131, 33F25H0746, 33F25J0784, 33F25L0006, 33F25M0903, 33F24D0391; ASK-17019-SM/10801902210217, 10801902211221/33F25G0137, 33F25H0136, 33F25J0553, 33F25L0465, 33F24B0348; BP-05501/10801902210217, 10801902193275/33F24E0156, 33F24J0642, 33F24K0270, 33F25B0689, 33F25C0868, 33F25E1034, 33F25G0145, 33F25H0158, 33F25J0568, 33F25L0369, 33F26B0518, 33F25C0444; CK-05401/10801902202144, 10801902210217, 10801902193275/33F24C0256, 33F25A0591, 33F25C0972, 33F25E0256, 33F25E1040, 33F25H0756, 33F25J0935, 33F25L0244, 33F26B0620, 33F25D0674; HS-05501/10801902210217, 10801902202090/33F24E0580, 33F24J0329, 33F24B0389; MM-05501/10801902210217/33F24J0655, 33F24K0287, 33F24L0788, 33F25J0628, 33F25L0445, 33F24C0263; MP-17019-TK/10801902210217/33F24D0409, 33F24J0390, 33F24K0288, 33F24L0546, 33F25A0595, 33F25C0727, 33F25E0262, 33F25E1045, 33F25H0170, 33F25J0629, 33F25L0441, 33F25M0939, 33F24D0410; MP-17019-TKD/10801902210217, 10801902210224/33F24J0657, 33F24L0698, 33F25C0760, 33F25E0263, 33F25H0171, 33F25J0938, 33F24B0152; MP-17019-TKL/10801902210224, 10801902210217/33F24D0038, 33F24K0289, 33F24L0614, 33F25C0190, 33F25C0839, 33F25E0264, 33F25G0149, 33F25J0630, 33F25K0380, 33F24K0290; MSO-05401-JMH/10801902210217/33F25C0193, 33F25H0172, 33F25J0631, 33F25L0375, 33F25M0880, 33F24D0413; NM-05401/10801902210217, 10801902210262, 10801902140644/33F25J0944, 33F25M0968, 33F26B0600, 33F24C0780; SJ-05501/10801902210330, 10801902210217, 10801902202496/33F24C0049, 33F24C0050, 33F24J0382, 33F24J0383, 33F24J0384, 33F24J0385, 33F24J0386, 33F24K0552, 33F24K0553, 33F24K0554, 33F24K0555, 33F24K0556, 33F24K0557, 33F24L0625, 33F24L0721, 33F24L0760, 33F24L0786, 33F25A0605, 33F25A0623, 33F25A0624, 33F25C0202, 33F25C0789, 33F25C0790, 33F25C0945, 33F25C0997, 33F25E0278, 33F25E0295, 33F25E0296, 33F25E1057, 33F25E1068, 33F25G0154, 33F25G0160, 33F25H0183, 33F25H0202, 33F25H0203, 33F25J0639, 33F25J0644, 33F25J0798, 33F25J0811, 33F25J0812, 33F25J0813, 33F26B0601, 33F26C0299, 33F26C0307, 33F24A1336; SM-05401/10801902210217, 10801902210354, 10801902193275/33F24G0561, 33F24K0302, 33F24L0607, 33F25C0204, 33F25C0805, 33F25E0279, 33F25E1058, 33F25H0184, 33F25J0948, 33F26A1030, 33F24G0270; TM-05401/10801902210217, 30801902202155, 10801902210361/33F24D0418, 33F24G0563, 33F24J0669, 33F24L0089, 33F24L0741, 33F25C0207, 33F25C0918, 33F25E0282, 33F25E1059, 33F25J0950, 33F25L0447, 33F26C0308, 33F24B0410; TM-05502/10801902210378/33F24B0411; UI-05502/10801902210217/33F24G0565, 33F24J0670, 33F24L0562, 33F25A0607, 33F25C0881, 33F25E0283, 33F25E1060, 33F25G0752, 33F25H0186, 33F25J0951, 33F24A0359; ASK-05400-SHM/10801902210217/33F24E0482, 33F24G0465, 33F24J0601, 33F24K0221, 33F24L0800, 33F25C0162, 33F25C0888, 33F25E0182, 33F25H0741, 33F25L0457, 33F24E0483; ASK-05400-UOM/10801902210217/33F25G0124, 33F25H0742, 33F25K0263, 33F24G0294; ASK-05500-MR/10801902210217, 10801902209730/33F24E0497, 33F24G0471, 33F24K0230, 33F25A0555, 33F25C0796, 33F25E0192, 33F25H0116, 33F25K0408, 33F25M0854, 33F24C0204; ASK-05500-TM/10801902210217, 10801902209747, 10801902209754/33F25C0165, 33F25E1007, 33F25M0871, 33F26C0256, 33F24C0206; ASK-05501-BHL1/10801902210217/33F24L0566, 33F25A0558, 33F25C0810, 33F25E0197, 33F25E1009, 33F25H0121, 33F25J0541, 33F25L0439, 33F24E0503; ASK-05501-GH/10801902210217, 10801902210392/33F24K0235, 33F25A0559, 33F25E0198, 33F25H0122, 33F25J0542, 33F24D0384; ASK-05501-SM/10801902210217, 10801902210392, 10801902214857/33F24E0505, 33F24K0236, 33F25A0560, 33F25C0808, 33F25E0199, 33F25E1010, 33F25H0123, 33F25J0907, 33F26C0304, 33F24C0210; ASK-05502-BSM/10801902209853, 10801902210217/33F24D0385, 33F24E0508, 33F24G0301, 33F24K0237, 33F25A0154, 33F25B0687, 33F25H0124, 33F25J0543, 33F25K0409, 33F25L0466, 33F26B0592, 33F24E0509; ASK-05502-MGH1/10801902210217, 10801902209860/33F24J0617, 33F24L0569, 33F25B0247, 33F25C0938, 33F25E0304, 33F25G0133, 33F25J0909, 33F25L0098, 33F26B0545, 33F24J0318; ASK-05503-BWB1/10801902210217, 10801902209938, 10801902209952/33F24E0514, 33F24G0481, 33F24J0619, 33F24K0241, 33F24L0690, 33F25C0169, 33F25C0756, 33F25E1011, 33F25J0545, 33F25L0453, 33F26B0584, 33F24C0217; ASK-05503-HMH/10801902210217, 10801902209952, 10801902209969/33F24L0643, 33F25A0563, 33F25C0170, 33F25C0765, 33F25E1012, 33F25G0135, 33F25H0127, 33F25J0546, 33F25L0451, 33F26A1079, 33F24C0218; ASK-05503-SPH/10801902210217, 10801902209969, 10801902211405/33F24E0516, 33F24J0620, 33F24K0243, 33F24L0598, 33F25A0564, 33F25E0204, 33F25L0458, 33F25M0951, 33F24C0219; ASK-05503-UPM1/10801902211405, 10801902210217, 10801902209976/33F24D0389, 33F24E0160, 33F24J0621, 33F24K0244, 33F24L0549, 33F25A0565, 33F25C0992, 33F25E0205, 33F25E1013, 33F25H0129, 33F25J0547, 33F25L0454, 33F24D0390; ASK-05560-UCI2/10801902210217, 10801902193275/33F24G0485, 33F24J0623, 33F24L0593, 33F25A0567, 33F25C0893, 33F25E0206, 33F25E1015, 33F25H0132, 33F25J0911, 33F25L0061; ASK-17019-UMP/10801902210217, 10801902211221, 10801902210057/33F24J0628, 33F24K0250, 33F25B0694, 33F25E0216, 33F25H0137, 33F25J0916, 33F26B1000, 33F24B0350; MH-05503-1/10801902210217/33F25H0169, 33F24G0542 ASK-05401-VB2/10801902214840/33F24C0199, 33F24D0374, 33F24E0486, 33F24G0296, 33F24J0312, 33F24J0605, 33F24K0224, 33F24L0733, 33F25A0549; ASK-05500-SC1 /10801902202250/33F24B0319, 33F24C0205, 33F24D0381, 33F24E0499, 33F24G0299, 33F24J0315, 33F24J0613, 33F24K0232, 33F24L0567, 33F25A0557, 33F25C0884, 33F25E0194; ASK-05500-SC3/10801902223651/33F25G0751, 33F25H0118, 33F26B0644; ASK-05501-AFH1/10801902209761/33F24G0475; ASK-05501-BMC/10801902209785/33F24J0479; ASK-05502-NY/10801902209884/33F24E0512; ASK-17019-RMH/10801902214918/33F24B0346, 33F24E0531

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 10 of 35

Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A

Z-2372-2026

Recall number: Z-2372-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 1180

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): CDC-25142-X1A/30801902123597, 10801902193275/36F25E0021, 33F25B0467

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 11 of 35

Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC; HEMODIALYSIS KIT 2L: 14 FR X 20CM AGB/AK-25142-CDC; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UMD; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UNC; HEMODIALYSIS KIT: 2L 14 FR X 20 CM/ASK-25142-UMD; HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB/ASK-25142-UN1; HEMODIALYSIS KIT: 2L 14 FR X 25 CM/ASK-26142-UMD; HEMODIALYSIS KIT: 2LUMEN 12 FR X 13 CM/AU-23122-F; HEMODIALYSIS KIT: 2LUMEN 12 FR X 20 CM/AU-25122-F; HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-X1A; HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-XU1A; HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB/CDC-22142-X1A; HEMODIALYSIS KIT: 2L 12 FR X 25 CM AGB/CDC-26122-X1A; HEMODIALYSIS KIT 2L: 12 FR X 16CM AGB/AK-22122-CDC; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122-F; HEMODIALYSIS KIT: 2-LUMEN 14 FR X 15 CM/AK-22142-F; AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-CN1AU; AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-CN1AC; AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-CN1AU; AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-CN1AU; AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-CN1AC;

Z-2373-2026

Recall number: Z-2373-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 15,425

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): AK-11802-F/10801902193275, 10801902197129/33F24G0344, 33F24J0511, 33F24L0637, 33F25A0473, 33F25E0060, 33F25J0473, 33F24A0848; AK-22122/10801902193275/33F24H0232, 33F24J0523; AK-22142-CDC/10801902193275/33F24J0527, 33F24K0129, 33F24L0649, 33F25C0115, 33F25C0959, 33F25E0940, 33F25J0481, 33F25L0428, 33F24G0364; AK-25142-CDC/10801902193275, 50801902123195/33F25A0486, 33F25C0892, 33F25E0086, 33F25E0944, 33F25J0485, 33F25J0845, 33F25L0374, 33F26B0521, 33F25A0487; ASK-22142-UMD/10801902193275, 10801902136470, 10801902143690/33F25F0362, 33F25J0094, 33F26A0244, 33F26B0137, 33F24F0041; ASK-22142-UNC/10801902193275/33F25G0269, 33F24K0560; ASK-25142-UMD/10801902193275, 10801902136500/33F25B0239, 33F25E0308, 33F25G0686, 33F25K0425, 33F26A0246, 33F26C0047, 33F24K0696; ASK-25142-UN1/10801902193275, 10801902156379/33F24L1157, 33F26B0908, 33F25B0420; ASK-26142-UMD/10801902193275, 33F26A0408, 33F25B0427; AU-23122-F/10801902193275/33F25C0877, 33F25H0157, 33F24L0038; AU-25122-F/10801902193275, 70801902123328, 10801902210071/33F25G0562, 33R24L0038, 33F24D0400; CDC-22122-X1A/10801902193275, 10801902213478/33F25E0694, 33F25G0268, 33F24D0693; CDC-22122-XU1A/10801902193275, 10801902168044/33F25E0652, 33F25H0643, 33F24D0830; CDC-22142-X1A/10801902193275/33F25A0284; CDC-26122-X1A/10801902213515/33F24F1028; AK-22122-CDC/10801902193275, 10801902198492/33F24K0125, 33F24L0647, 33F25C0114, 33F25E0936, 33F25G0091, 33F24E0355; AK-22122-F/10801902193275/33F24G0360, 33F24J0524, 33F24K0126, 33F25A0482, 33F25E0075, 33F25E0937, 33F25J0839, 33F25L0413, 33F24G0361; AK-22142-F/10801902193275/33F24L0662, 33F25C0117, 33F25C0865, 33F25H0034, 33F25J0841, 33F24K0130; CDC-22122-CN1AU/10801902193275, 10801902222265/33F26A1388, 33F26B0398, 33F24L0966; CDC-22142-CN1AC/10801902193275/33F26A1550, 33F25J0455; CDC-23122-CN1AU/10801902193275, 10801902222319/33F26A0008, 33F26A1478, 33F26B0397, 33F24L0279; CDC-25122-CN1AU/10801902193275/33F25M0346, 33F25E0882; CDC-25142-CN1AC/30801902123597/36F25B0018

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 12 of 35

Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPN1A; AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-XN1A-U; LBCVC AGB KIT: 3-L 12 FR X 16 CM/CDC-22123-XN1A

Z-2374-2026

Recall number: Z-2374-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 4,270

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): AK-12123-PCDC/10801902193275, 10801902168471/33F24J0419, 33F25B0015, 33F25F0022, 33F25G0482, 33F25J0029, 33F25K0268, 33F26B0056, 33F24E0175; AK-15123-PCDC/10801902186499, 10801902193275, 10801902168532/33F24G0140, 33F24J0449, 33F24M0074, 33F25B0040, 33F25J0604, 33F24A0767; CDC-15123-XP1A/10801902193275, 30801902111822, 10801902213430/33F25D0438, 33F25E0649, 33F25H0579, 33F25J0313, 33F26B0161, 33F26C0198, 33F24D0355; CDC-16123-XP1A/10801902193275, 40801902111867/33F25D0612, 33F25G0291, 33F25H0578, 33F26C0190, 33F24L0469; CDC-16123-XPN1A/10801902193275, 10801902196498/33F25J0113, 33F24D0974; CDC-25122-XN1A-U/10801902193275/33F25J0114, 33F25B0621; CDC-22123-XN1A/50801902123515/33F24D0928

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 13 of 35

Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PNHS2; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PNHS2

Z-2375-2026

Recall number: Z-2375-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 0

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): ASK-42703-PNHS2/10801902193275/33F25J0107; ASK-45703-PNHS2/10801902193275/33F25B0593; ASK-45854-PNHS2/10801902193275/33F24H0128

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 14 of 35

Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PMAH; 3L PI CVC KIT: 7 FR X 16 CM/ASK-12703-PNM; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PUMH; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-15703-PRH; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/CDC-15703-P1A; PI CVC KIT: 3-L 7 FR X 6IN (16 CM)/NA-12703-PCDC; PI CVC KIT: 3-L 7 FR X 8IN (20 CM)/NA-15703-PCDC; CVC KIT: 3-LUMEN 5.5 FR X 8 CM/AK-25553; 2-L CVC KIT: 4 FR X 5 CM/CDC-22402-X1A; 2-L CVC KIT: 5 FR X 5 CM/CDC-22502-X1A; 2-L CVC KIT: 4 FR X 8 CM/CDC-25402-X1A; 2-L CVC KIT: 5 FR X 8 CM/CDC-25502-X1A; 3-L CVC KIT: 5.5 FR X 8 CM/CDC-25553-X1A; 3-L CVC KIT: 5.5 FR X 13 CM/CDC-26553-X1A; CVC KIT 3L: 12 FR X 16 CM AGB/AK-22123-CDC; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-22123-F; CVC KIT: 2-LUMEN 4 FR X 5 CM/AK-22402; CVC KIT: 2-LUMEN 5 FR X 5 CM/AK-22502; CVC KIT: 16 GA X 8IN/AK-24301-SK; CVC KIT: 2-LUMEN 4 FR X 13 CM/AK-24402; CVC KIT: 3-LUMEN 7 FR X 30 CM/AK-24703-ASK; CVC KIT 3L: 12FR X 20 CM AGB/AK-25123-CDC; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-25123-F; CVC KIT: 2-LUMEN 4 FR X 8 CM/AK-25402; CVC KIT: 2-LUMEN 5 FR X 8 CM/AK-25502; CVC KIT: 3-LUMEN 5.5 FR X 13 CM/AK-26553; LBCVC KIT: 3L 12 FR X 16 CM AGB/CDC-22123-1A; LBCVC KIT: 3L 12 FR X 16 CM AGB/CDC-22123-X1A; CVC KIT: 16 GA X 20 CM/CDC-24301-1A; PI CVC KIT: 2L 7 FR X 16 CM AGB/AK-22702-P1A; PI CVC KIT: 2L 7 FR X 16 CM AGB/CDC-22702-XP1A; CVC KIT: 3L 7 FR X 20 CM/ASK-45703-CPR; MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-AKP1A; MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6IN/ASK-42703-KH; PI CVC KIT: 3L 7FR X 16CM AGB+/ASK-42703-MGH1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6IN/ASK-42703-PCCH2; PI CVC KIT: 3LUMEN 7 FR X 6IN (16 CM)/ASK-42703-PFS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNO2; MULTI LUMEN PI CVC KIT: 3L 7 FR/ASK-42703-PSCH1; MULTILUMEN PI CVC KIT: 2L 8 FR X 16 CM/ASK-42802-AKP1A; CVC KIT: 2L 8 FR X 16CM/ASK-42802-LMDTG1; PI CVC KIT: 2L 8 FR X 6 IN (16 CM) AGB+/ASK-42802-PUCI1; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PUMH; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-UMM; PI CVC KIT: 4-L 8.5 FR X 6 IN/ASK-42854-AKP1A; PI CVC KIT: 4L 8.5FR X 16CM AGB+/ASK-42854-MGH; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-AKP1A; PI CVC KIT: 3L 7 FR X 20CM AGB+/ASK-45703-MGH; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PCCH2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PECL1; PI CVC KIT: 3 LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-PFS1; PI CVC KIT: 3L 7 FR X 8 IN (20 CM) AGB+/ASK-45703-PHM1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PHU; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PMSG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PNCB; MULTILUMEN CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PPCM; PI CVC KIT: 3-LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-PRH; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PSJ2; PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PSVM; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PUHS; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PUKL; PI CVC KIT: 3L 7FR X 20CM AGB+/ASK-45703-PUMF1; PI CVC KIT: 3L 7 FR X 8 IN (20 CM)/ASK-45703-PUR1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-RHR1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-WA; MULTI LUMEN PI CVC KIT: 2L 8 FR X 8 IN/ASK-45802-AKP1A; PI CVC KIT: 4L 8.5 FR X 20 CM/ASK-45854-AKP1A; PI CVC KIT: 4L 8.5FR X 20CM AGB+/ASK-45854-MGH; PI CVC KIT: 4L 8.5 FR X 8IN/ASK-45854-PCCH2; CVC KIT: 4L 8.5 FR X 20 CM AGB/ASK-45854-PNM; MULTI LUMEN CVC KIT: 4L 8.5 FR X 8 IN/ASK-45854-PPCM; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PUCH2; MULTILUMEN PI CVC KIT: 2L 7 FR X 20 CM/ASK-46702-PWBH1; MULTILUMEN CVC KIT: 2L 8 FR X 16 CM/CDC-42802-P1A; PI CVC KIT: 3-L 7 FR X 20 CM AGB/CDC-45703-PA1A; CVC KIT: 2L 8 FR X 6IN (16 CM)/ASK-42802-ECL4; PI CVC KIT: 3-L 7 FR X 16 CM AGB+/AK-42703-P1A; PI CVC KIT: 2-L 8 FR X 16 CM AGB+/AK-42802-P1A; PI CVC KIT: 4-L 8.5 FR X 16 CM AGB+/AK-42854-P1A; PI CVC KIT: 3-L 7 FR X 20 CM AGB+/AK-45703-P1A; PI CVC KIT: 2-L 8 FR X 20 CM AGB

Z-2376-2026

Recall number: Z-2376-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 308,263

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): ASK-42802-PLH/10801902193275, 10801902133110, 10801902212013/33F25L0140 33F26B0222, 33F24F0799; AK-12123-F/10801902168464, 10801902193275, 10801902186338/33F24B0185, 33F24C0102, 33F24D0077, 33F24F0323, 33F24G0346, 33F24K0112, 33F25C0929, 33F25E0062, 33F25H0028, 33F25J0833, 33F24G0129; AK-15123-F/10801902168525, 10801902193275, 10801902186499/33F24C0108, 33F24E0349, 33F24G0353, 33F24L0650, 33F25A0478, 33F25C0779, 33F25E0068, 33F25M0946, 33F24E0713; ASK-12703-PMAH/10801902193275/33F24J0116; ASK-12703-PNM/10801902193275, 10801902214338/33F24L0197, 33F24D0725; ASK-12703-PUMH/10801902193275, 10801902164602/33F25L0030, 33F24F0914; ASK-15703-PRH/10801902193275, 10801902133226/33F25C0271, 33F25F0168, 33F25J0101, 33F25J0368, 33F26A1500, 33F24C0858; CDC-15703-P1A/10801902116793, 10801902193275/33F24D0980, 33F24E0236, 33F24E0832, 33F24G0252, 33F24H0074, 33F24H0401, 33F24H0457, 33F24J0195, 33F24K0024, 33F24M0016, 33F24M0017, 33F24M0064, 33F25B0116, 33F25C0577, 33F25D0719, 33F25G0427, 33F25G0441, 33F25G0663, 33F25H0361, 33F25J1039, 33F25M0495, 33F25M0512, 33F25B0670; NA-12703-PCDC/10801902193275, 10801902119978, 10801902119985/33F24G0555, 33F24K0298, 33F25A0602, 33F25E1055, 33F25H0180, 33F25J0942, 33F25L0474, 33F26B0598, 33F24D0414; NA-15703-PCDC/10801902119985, 10801902193275, 10801902119985, 10801902210217/33F24F0191, 33F24G0556, 33F24J0336, 33F24K0572, 33F25A0157, 33F25C0200, 33F25C0833, 33F25E0275, 33F25H0181, 33F25H0762, 33F25J0943, 33F25L0456, 33F26B0587, 33F25A0603; AK-25553/10801902193275, 10801902167801/33F24H0250, 33F24M0062, 33F25A0382, 33F25B0310, 33F25C0069, 33F25C0506, 33F26C0405, 33F24G0377; CDC-22402-X1A/)10801902193275/33F25K0177, 33F26B0893, 33F25E1192; CDC-22502-X1A/10801902193275/33F25F0216, 33F25C0331; CDC-25402-X1A/10801902193275, 20801902116974/33F25A0287, 33F25D0505, 33F25E0824, 33F25H0569, 33F26A1470, 33F26B0216, 33F24L0486; CDC-25502-X1A/10801902193275/33F24L0980, 33F25D0506, 33F25E0698, 33F25G0315, 33F25J0429, 33F26A1472, 33F24L0832; CDC-25553-X1A/10801902193275, 10801902168129, 60801902123611/33F25E0890, 33F25E1191, 33F26A1384, 33F26B0708, 33F24F0084; CDC-26553-X1A/10801902193275, 10801902168136, 50801902117019/33F25E0749, 33F25E1190, 33F25J0432, 33F26B0807, 33F26C0210, 33F26D0063, 33F24D0807; AK-22123-CDC/10801902193275, 10801902167740/33F24K0127, 33F25A0483, 33F25E0076, 33F25E0938, 33F25H0032, 33F25J0480, 33F25K0398, 33F25M0960, 33F24E0358; AK-22123-F/10801902193275/33F24G0362, 33F24J0526, 33F24K0128, 33F24L0762, 33F25C0963, 33F25E0939, 33F25H0033, 33F24G0363; AK-22402/10801902193275, 10801902167764/33F24L0704, 33F25A0484, 33F25C0817, 33F25E0079, 33F25H0035, 33F25L0373, 33F25M0879, 33F24B0203; AK-22502/10801902193275, 10801902167764/33F24E0363, 33F24G0366, 33F24K0131, 33F24L0708, 33F25C0885, 33F25J0842, 33F24K0487; AK-24301-SK/10801902193275/33F24G0367, 33F24J0528, 33F24K0132, 33F24L0680, 33F25C0118, 33F25C0775, 33F25E0080, 33F25G0092, 33F25H0036, 33F25H0724, 33F25J0482, 33F25L0411, 33F25M0915, 33F24K0133; AK-24402/10801902193275/33F24L0059, 33F24L0727, 33F25C0119, 33F25C0976, 33F25E0081, 33F24K0134; AK-24703-ASK/10801902193275, 10801902118971, 60801902123178/33F24L0778, 33F25C0928, 33F25E0082, 33F25H0037, 33F25J0843, 33F26B0495, 33F24F0281; AK-25123-CDC/10801902193275/33F24K0136, 33F24L0730; AK-25123-F/10801902193275/33F25C0913, 33F25E0085, 33F25E0943, 33F25J0484, 33F26B0496, 33F24G0374; AK-25402/10801902193275, 10801902167795/33F24G0376, 33F24J0282, 33F24K0139, 33F24L0752, 33F25C0121, 33F25C0968, 33F25G0093, 33F25J0486, 33F25L0381, 33F26B0532, 33F24G0688; AK-25502/10801902193275, 10801902180381/33F24H0051, 33F24M0001, 33F25A0125, 33F25B0333, 33F25F0256, 33F25F0500, 33F25H0807, 33F25K0228, 33F25L0163, 33F26A0051, 33F26B0266, 33F24G0689; AK-26553/10801902193275, 20801902117506/33F24K0140, 33F24L0776, 33F25E0089, 33F25G0094, 33F25J0847, 33F25L0410, 33F25M0914, 33F24D0024; CDC-22123-1A/10801902168044, 10801902193275/33F24F0943, 33F24L0472, 33F25A0325, 33F25B0672, 33F25E0653, 33F25E0877, 33F25M0114, 33F25M0424, 33F26A1508, 33F25A0326; CDC-22123-X1A/10801902193275, 20801902116851, 20801902116851,10801902213591/33F25B0673, 33F25D0446, 33F25D0667, 33F25F0212, 33F25G0413, 33F25J0317, 33F25M0396, 33F26B0442, 33F24D0842; CDC-24301-1A/30801902116902, 10801902193275, 30801902116902, 30801902116919/33F24D0874, 33F24F0076, 33F24F0863, 33F24K0501, 33F24L0979, 33F25B0617, 33F25D0494, 33F25D0668, 33F25E0697, 33F25E0820, 33F25H0571, 33F25J0249, 33F25K0181, 33F25L0084, 33F25L0104, 33F26A1413, 33F26B0784, 33S25E0697, 33F24C0702; AK-22702-P1A/10801902193275, 30801902122378/33F25D0322, 33F25H0424, 33F25J0097, 33F25K0085, 33F24E0364; CDC-22702-XP1A/10801902193275, 30801902116896/33F25D0451, 33F25F0217, 33F25H0573, 33F25J0322, 33F26A1386, 33F26B0706, 33F25K0180; ASK-45703-CPR/10801902193275/33F24J0477, 33F24L1068; ASK-42703-AKP1A/10801902193275, 10801902202519/33F24J0324, 33F25A0577, 33F25C0841, 33F25E0233, 33F25E1027, 33F25G0140, 33F25H0148, 33F25H0754, 33F25J0924, 33F25M0869, 33F24F0754; ASK-42703-KH/10801902193275, 10801902205657/33F24G0269, 33F24L0087, 33F25E0235, 33F25G0141, 33F25L0213, 33F24D0891; ASK-42703-MGH1/10801902193275, 10801902223682, 10801902193275/33F25J0735, 33F26C0344, 33F25E0509; ASK-42703-PCCH2/10801902193275, 10801902141030/33F24L0231, 33F24L0416, 33F24L0945, 33F25B0443, 33F25B0561, 33F25D0352, 33F25E0726, 33F25G0316, 33F25J0155, 33F25M0013, 33F26B0792, 33F26C0228, 33F25D0540; ASK-42703-PFS1/10801902193275/33F25E0598, 33F25B0275; ASK-42703-PNO2/10801902193275/33F26A1661, 33F24L0335; ASK-42703-PSCH1/10801902137330, 10801902193275/33F24F1038, 33F24H0204, 33F25B0566, 33F25H0491, 33F25J0274, 33F25M0092, 33F26B0124, 33F24H0100; ASK-42802-AKP1A/10801902193275, 10801902217155/33F24G0511, 33F24K0264, 33F24L0745, 33F25C0931, 33F25H0150, 33F25J0561, 33F25L0481, 33F25M0971, 33F24F0676; ASK-42802-LMDTG1/10801902193275, 10801902205701/33F26A1254, 33F26B0814, 33F24H0215; ASK-42802-PUCI1/10801902193275/33F24L0195; ASK-42802-PUMH/10801902193275, 10801902164251/33F25H0493, 33F25K0059, 33F25L0141, 33F25M0674, 33F24D0712; ASK-42802-UMM/10801902159653, 10801902193275/33F24F1027, 33F24G0513; ASK-42854-AKP1A/10801902193275, 10801902202540/33F24J0635, 33F24K0265, 33F24L0610, 33F25A0580, 33F25E0239, 33F25H0152, 33F25J0562, 33F24E0632; ASK-42854-MGH/10801902223668, 10801902193275/33F26C0876, 33F25E1198; ASK-45703-AKP1A/10801902193275, 10801902158120/33F24G0515, 33F24J0636, 33F24K0266, 33F24L0577, 33F25A0581, 33F25C0843, 33F25E0241, 33F25G0142, 33F25H0154, 33F25J0564, 33F25L0238, 33F25M0902, 33F24F0106; ASK-45703-MGH/10801902223675/33F26C0875, 33F25B0580; ASK-45703-PCCH2/10801902193275, 10801902141047, 10801902193275/33F24L0356, 33F24L1092, 33F25B0582, 33F25D0550, 33F25E0615, 33F25G0352, 33F25J0163, 33F25K0154, 33F26B0772, 33F24L0088; ASK-45703-PECL1/10801902193275, 10801902130386/33F25E0618, 33F25F0204, 33F25G0289, 33F25J0167, 33F25M0192, 33F26B0191, 33F26B0765, 33F25C0313; ASK-45703-PFS1/10801902193275/33F25E0510, 33F25B0274; ASK-45703-PHM1/10801902193275, 10801902116229/33F25E0620, 33F25G0290, 33F25H0572, 33F25J0405, 33F26B0715, 33F26B0854, 33F25K0313; ASK-45703-PHU/10801902193275/33F25L0135, 33F26A0243, 33F25G0685; ASK-45703-PMSG1/10801902193275, 30801902116315/33F25E1199, 33F25F0357, 33F26A0411, 33F24D0674; ASK-45703-PNCB/30801902116315, 10801902193275/33F24F0818, 33F24L0256, 33F24L1075, 33F25B0592, 33F25D0486, 33F25E0731, 33F25H0433, 33F25M0159, 33F25M0426, 33F26B0760, 33F25B0456; ASK-45703-PPCM/10801902193275, 10801902116335/33F25F0358, 33F25G0688, 33F25K0048, 33F25L0028, 33F26B0903, 33F24K0067; ASK-45703-PRH/10801902193275, 10801902116359, 10801902116373/33F25A0275, 33F25C0318, 33F25E0807, 33F25G0358, 33F25J0301, 33F26A1420, 33F26B0799, 33F24E0560; ASK-45703-PSJ2/10801902193275, 10801902119732/33F25C0319, 33F25E0733, 33F25G0357, 33F25H0641, 33F25J0302, 33F26A1507, 33F26B0878, 33F24L0259; ASK-45703-PSVM/10801902119749, 10801902193275, 10801902119749/33F24F0755, 33F24L0446, 33F25B0459, 33F25C0320, 33F25D0551, 33F25F0120, 33F25G0356, 33F25J0303, 33F26A1523, 33F26B0762, 33F25D0237; ASK-45703-PUHS/10801902193275, 10801902114058/33F24L0942, 33F25B0596, 33F25E0687, 33F25G0303, 33F25H0642, 33F26A1424, 33F24F0717; ASK-45703-PUKL/10801902193275, 10801902114058, 10801902193275/33F24H0185, 33F24K0433, 33F24L0262, 33F25B0597, 33F25D0372, 33F25E0628, 33F25H0566, 33F25J0173, 33F26B0233, 33S25E0628, 33F25B0461; ASK-45703-PUMF1/10801902193275/33F25K0060, 33F25L0134, 33F26A0235, 33F24K0567; ASK-45703-PUR1/10801902116465, 10801902193275/33F24F0790, 33F24H0206, 33F24L0266, 33F24L0922, 33F25B0601, 33F25D0375, 33F25E0630, 33F25E0870, 33F25J0408, 33F25M0128,33F26A1432, 33F26B0836, 33F24G0616; ASK-45703-RHR1/10801902116465, 10801902193275/33F24F0790, 33F24H0206, 33F24L0266,33F24L0922, 33F25B0601,33F25D0375, 33F25E0630, 33F25E0870, 33F25J0408, 33F25M0128, 33F26A1432, 33F26B0836, 33F24G0616; ASK-45703-WA/10801902193275, 10801902116564, 30801902119774/33F25A0443, 33F25E0011, 33F25K0309, 33F26B0909, 33F24C0746; ASK-45802-AKP1A/10801902193275, 30801902119774/33F24L0023, 33F26A1657, 33F26B0277, 33F25D0034; ASK-45854-AKP1A/10801902193275, 30801902119781/33F24G0671, 33F24L0039, 33F25A0366, 33F25B0094, 33F25D0715, 33F25G0495, 33F25J0033, 33F25K0349, 33F25L0226, 33F26A1654, 33F26B0025, 33F26B0698, 33F24J0130; ASK-45854-MGH/10801902223699, 10801902193275/33F26C0688, 33F25C0363; ASK-45854-PCCH2/10801902193275/33F25J0234, 33F25E1175; ASK-45854-PNM/10801902193275/33F24K0570, 33F25B0431, 33F25E0006, 33F25F0377, 33F25H0780, 33F25L0261; ASK-45854-PPCM/10801902143867/33F24F0736; ASK-45854-PUCH2/10801902193275/33F24M0177; ASK-46702-PWBH1/10801902193275/33F24K0321, 33F24K0269; CDC-42802-P1A/10801902170870, 10801902193275, 10801902170870/33F24F0244, 33F24H0070, 33F24H0426, 33F24J0223, 33F24J0468,33F24L0009,33F24M0079, 33F24M0139, 33F25B0319, 33F25C0533, 33F25E1094, 33F25E1156,33F25F0384, 33F25H0338, 33F25J0766, 33F25J0990, 33F25L0086, 33F25M0016, 33F26A1619, 33F26B1051, 33F25H0880; CDC-45703-PA1A/10801902193275, 30801902117190, 10801902117202/33F24M0081, 33F25F0241, 33F26A1656, 33F26B0334, 33F24C1072; ASK-42802-ECL4/10801902224283, 10801902205664/33F26B0489, 33F24D0651; AK-42703-P1A/10801902193275, 10801902171372/33F25D0323, 33F25D0585, 33F25F0122, 33F25F0153, 33F25G0376, 33F25J0135, 33F26B0459, 33F24L1104; AK-42802-P1A/10801902193275/33F25B0539, 33F25D0386, 33F25F0137, 33F25J0136, 33F25B0512; AK-42854-P1A/10801902193275, 10801902168167, 10801902119152/33F25E0664, 33F25H0442, 33F25J0341, 33F26B0752, 33F23H0557; AK-45703-P1A/10801902193275, 10801902171389/33F25C0341, 33F25D0387, 33F25D0643, 33F25F0154, 33F25G0257, 33F25G0375, 33F25J0137, 33F25J0342, 33F26A1416, 33F26B0150, 33F26B0766, 33F25C0191; AK-45802-P1A/10801902193275, 10801902168181/33F25E0665, 33F25J0191, 33F26B0754, 33F25A0223; AK-45854-P1A/10801902193275, 10801902168198/33F25D0459, 33F25F0138, 33F26B0145, 33F25B0540; AK-47702-P1A/10801902193275/33F25E0502, 33F25G0162, 33F25H0407, 33F25J0343, 33F24G0383; ASK-42703-PECL3/10801902193275/33F26A1397, 33F25B0562; ASK-42703-PUPM3/10801902225150, 10801902156966/33F26C0238, 33F24F0977; ASK-42802-PUPM3/10801902225143, 10801902193275/33F26C0239, 33F25B0498; ASK-45703-PECL3/10801902193275, 10801902224313/33F26A1577, 33F26B0773, 33F25C0234; ASK-45703-PUPM3/10801902225181, 10801902116465/33F26C0219, 33F24D0840; ASK-45854-PECL3/10801902193275/33F24L0191; ASK-45854-PUPM3/10801902225167, 10801902193275/33F26C0240, 33F24H0111; ASK-45854-SMW/10801902224436, 10801902214888/33F26B0830, 33F24F0872; CDC-42802-XP1A/10801902193275, 10801902168365, 10801902162103/33F25J0295, 33F25J0728, 33F25K0304, 33F25K0390, 33F25L0228, 33F25M0037, 33F25M0485, 33F25M0717, 33F26A1630, 36F25C0008, 36F25D0001, 36F25D0034, 36F25E0001, 36F25G0022, 36F25H0015, 33F24D0258; CDC-42854-XP1A/10801902193275, 20801902117148, 10801902162134/33F25J0681, 33F26A0390, 33F26C0209, 33F26D0062, 36F25D0003, 36F25H0014, 33F24D0827; CDC-45703-XP1A/10801902193275, 20801902117216/33F25G0286, 33F25H0876,33F25J0089,33F25J0682, 33F25J0702, 33F25J0705, 33F25J0711,33F25J0718, 33F25J0729, 33F25J0733, 33F25K0305, 33F25L0063,33F25L0093, 33F25L0094, 33F25L0231, 33F25L0252, 33F25L0253, 33F25L0254, 33F25L0286, 33F25L0302, 33F25L0322, 33F25M0487, 33F26A0062, 33F26B0637, 33F26B0638, 33F26D0185, 36F25A0008, 36F25A0014, 36F25D0010, 36F25D0011, 36F25D0014, 36F25D0021, 36F25D0022, 36F25D0023, 36F25D0028, 36F25D0041, 33F25C0372; CDC-45854-XP1A/10801902193275, 10801902169720, 10801902162158/33F25J0695, 33F25J0730, 33F25K0394, 33F26A1620, 33F26B0572, 33F26B0735, 36F25G0003, 36F25G0021, 36F25G0024, 36F25H0011, 36F25H0017, 33F24D0424 ASK-42703-PGM3/10801902213751/33F24F0951, 33F24K0743; ASK-42802-UH1/10801902156386/33F24H0122; ASK-45703-PGM3/10801902213768/33F24D0844, 33F24F0840;

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 15 of 35

Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSEL CATH KIT: 20GA X 5IN/AK-04550-S CVC KIT: 1-LUMEN 5 FR X 20 CM/AK-04301-SP CVC KIT: 16 GA X 6IN (16 CM)/AK-04306-SP CVC KIT: 16GA X 6 IN/AK-04800-S CVC KIT: 2-LUMEN 4 FR X 5 CM/AK-12402 CVC KIT: 3-LUMEN 7 FR X 16 CM/AK-12703-CDC CVC KIT: 2L 4 FR X 13 CM/AK-14402 CVC KIT: 2-LUMEN 5 FR X 13 CM/AK-14502 CVC KIT: 3-LUMEN 5.5 FR X 30 CM/AK-14553 CVC KIT: 3-LUMEN 7 FR X 30 CM/AK-14703-SP CVC KIT: 2-LUMEN 4 FR X 8 CM/AK-15402 CVC KIT: 3-LUMEN 5.5 FR X 8 CM/AK-15553 CVC KIT: 2-LUMEN 4 FR X 30 CM/AK-16402 CVC KIT: 3-LUMEN 5.5 FR X 13 CM/AK-16553 CVC KIT: 5 FR X 20 CM/ASK-04301-HH2 CVC KIT 3L: 7 FR X 6 IN (16 CM)/ASK-12703-MGH3

Z-2377-2026

Recall number: Z-2377-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 126,530

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

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Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): ASK-04510-MM6/10801902193275, 10801902221909/33F25E0590, 33F25G0196, 33F25M0005, 33F25M0149, 33F26A0302, 33F26C0723, 33F24K0212; NA-04020-X1ASP/10801902193275/33F25J0575, 33F25J0756, 33F26B0065, 33F26B0027; ASK-04001-MS/10801902193275/33F24K0706, 33F25F0375, 33F25F0005; ASK-00820-UM1/10801902193275/33F24G0150; AK-04550-S/10801902196719, 10801902193275, 60801902121709/33F24A0029, 33F24A0355, 33F24A1014, 33F24A1619, 33F24B0112, 33F24C0548, 33F24D0017, 33F24E0174, 33F24G0328, 33F24G0576, 33F24J0276, 33F24J0494, 33F24K0092, 33F24L0720, 33F25A0458, 33F25C0950 33F25E0041, 33F25E0911, 33F25G0080, 33F25H0013, 33F25J0820, 33F25L0402, 33F26B0550, 33F26C0267, 33F23M0175; AK-04301-SP/10801902121650, 10801902193275, 10801902121674/33F24A1010, 33F24C0093, 33F24D0068, 33F24E0325, 33F24G0325, 33F24J0274, 33F24K0090, 33F24L0809, 33F25C0757, 33F25E0038, 33F25G0760, 33F25H0721, 33F25J0462, 33F25L0239, 33F25M0888, 33F24A0146; AK-04306-SP/10801902121674, 10801902193275, 10801902192230/33F24A0846, 33F24B0174, 33F24C0094, 33F24E0327, 33F24E0329, 33F24J0275, 33F24J0492, 33F24L0717, 33F25B0249, 33F25C0783, 33F25E0039, 33F25J0463, 33F25L0054, 33F25L0345, 33F26B0684, 33F23J0175; AK-04800-S/60801902121709, 10801902193275, 10801902209501/33F24B0437, 33F24C0735, 33F24E0708, 33F24G0120, 33F24G0647, 33F24H0415, 33F24J0448, 33F24L0037, 33F24M0128, 33F25A0396, 33F25B0111, 33F25D0028, 33F25G0509, 33F25H0326, 33F25J0997, 33F26C0274, 33F24C0013; AK-12402/10801902168471, 10801902193275, 10801902168488/33F24E0342, 33F24F0325, 33F24G0347, 33F24J0512, 33F24K0113, 33F24L0750, 33F25C0109, 33F25C0964, 33F25E0063, 33F25E0926, 33F25J0474, 33F24A0408; AK-12703-CDC/10801902168488, 10801902193275, 10801902168495/33F24A1020, 33F24B0187, 33F24C0104, 33F24D0078, 33F24G0348, 33F24J0513, 33F24K0114, 33F24L0596, 33F25C0110, 33F25C0759, 33F25J0834, 33F25M0948, 33F24A0401; AK-14402/10801902168495, 10801902193275, 10801902168495, 10801902168518/33F24E0177, 33F24E0343, 33F24F0328, 33F24G0349, 33F24J0514, 33F24K0115, 33F25B0369, 33F25C0875, 33F25E0064, 33F25E0928, 33F25H0029, 33F25J0475, 33F26B0564, 33F24A0813; AK-14502/10801902168518, 10801902193275, 30801902122040/33F24E0344, 33F24G0350, 33F24K0116, 33F24L0656, 33F25C0878, 33F25E0065, 33F25G0089, 33F25J0476, 33F26B0568, 33F24A0849; AK-14553/30801902122040, 10801902193275, 10801902122077/33F24B0190, 33F24C0107, 33F24E0345, 33F24E0346, 33F24F0332, 33F24G0351, 33F24K0117, 33F24L0689, 33F25C0112, 33F25C0848, 33F25G0090, 33F25J0835, 33F24B0191; AK-14703-SP/10801902122077, 10801902193275, 10801902197136/33F24E0347, 33F24G0352, 33F24J0516, 33F24K0118, 33F24L0737, 33F25A0476, 33F25C0887, 33F25E0067, 33F25E0929, 33F25J0477, 33F25L0399, 33F25M0905, 33F24D0079; AK-15402/10801902168532, 10801902193275, 10801902168532, 10801902168549/33F24B0194, 33F24E0350, 33F24G0354, 33F24H0034, 33F24J0518, 33F24K0120, 33F24L0751, 33F25A0479, 33F25C0799, 33F25E0069, 33F25E0932, 33F25H0723, 33F25J0836, 33F25L0348, 33F26C0317, 33F24A1268; AK-15553/10801902168549, 10801902193275, 10801902168549, 10801902168563/33F24E0714, 33F24G0226, 33F24G0687, 33F24H0249, 33F24J0353, 33F25B0332, 33F25D0195, 33F25H0796, 33F25J0081, 33F26B0287, 33F24A1269; AK-16402/10801902168563, 10801902193275, 10801902168563, 10801902168570/33F24C0738, 33F24E0715, 33F24H0065, 33F24H0416, 33F24J0212, 33F24J0426, 33F25A0046, 33F25C0087, 33F25C0604, 33F25G0458, 33F25J0082, 33F26A1658, 33F26B0069, 33F26C0446, 33F24A0796; AK-16553/10801902168570, 10801902193275, 30801902122248/33F24E0178, 33F24E0351, 33F24G0355, 33F24J0519, 33F24K0121, 33F24L0790, 33F25C0980, 33F25E0070, 33F25J0478, 33F24C0025; ASK-04301-HH2/10801902193275, 20801902114987/33F25H0640, 33F25K0070, 33F25K0090, 33F24D0733; ASK-12703-MGH3/10801902193275, 10801902115260/33F25D0263, 33F24F0838

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 16 of 35

Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR x 55CM w Biopatch/DLX-45541-HPKB; PICC/DELTA KIT: 2L 5.5 FR X 50 CM/ASK-45052-MC; AGBA PI PICC KIT: 1L 4.5FR 40CM/CDC-44041-HPK1A; AGBA PI PICC KIT 2-LUMEN: 5.5 FR X 40CM/CDC-44052-HPK1A; AGBA PICC/DELTA FG: 2-L 5.5 FR X 40 CM/CDC-44052-VPS2; PI AGBA PICC KIT: 3-L 6 FR X 50 CM/CDC-45063-HPK1A; AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM/CDC-45541-VPS2; AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM/CDC-45552-VPS2; PICC/VPS 1L 4.5 FR/ASK-45541-CHS; PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI2; PICC KIT: 2L 5.5FR 55CM AGBA VPS/ASK-45552-CHS; PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI2; PICC KIT: 3L 6FR 55CM AGBA/ASK-45563-CHS; PI JACC KIT: 3L 6 FR X 25 CM CG+/ASK-42563-LTAC; PI JACC KIT: 1-L 4.5 FR X 25 CM CG+/CDC-42541-JX1A; PI JACC KIT: 2-L 5.5 FR X 25 CM CG+/CDC-42552-JX1A; PI JACC KIT: 3-L 6 FR X 25 CM CG+/CDC-42563-JX1A; PI JACC KIT: 2-L 5.5 FR X 30 CM CG+/CDC-43052-JX1A; PI JACC KIT: 3-LUMEN: 6 FR X 30 CM CG+/CDC-43063-JX1A; PICC KIT: 2-L 4 FR X 55 CM/CDC-05542-PK1A

Z-2378-2026

Recall number: Z-2378-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 3,481

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): DLX-35563-HPKC/10801902193275/33F25D0520; ASK-44552-ABKB/10801902140798, 10801902216677/33X25K0002, 33S24A0529; ASK-45552-MHBV/10801902193275/33F25K0372, 33F25M0199, 33F26A1534, 33F24L0348; DLX-45541-HPKB/10801902193275, 10801902208849/33F25G0393, 33F25L0055, 33F26A1570, 33F24D0604; ASK-45052-MC/10801902216660/33S24A1242; CDC-44041-HPK1A/10801902193275/33F24K0430; CDC-44052-HPK1A/10801902193275/33F25D0241; CDC-44052-VPS2/10801902193275/33F25E0514; CDC-45063-HPK1A/10801902193275/33F25D0242; CDC-45541-VPS2/50801902120781, 10801902193275/33S24A0211, 33F25C0699; CDC-45552-VPS2/10801902193275/33F25E0704; ASK-45541-CHS/10801902193275/33F26A1422, 33F24L0897; ASK-45541-UOI2/10801902193275/33F24L0991; ASK-45552-CHS/10801902193275/33F26A1395, 33F25G0260; ASK-45552-UOI2/10801902193275/33F24L0431; ASK-45563-CHS/10801902193275/33F25A0199; ASK-42563-LTAC/10801902203271/33F24F0852; CDC-42541-JX1A/10801902193275/33F26A1469, 33F24J0135; CDC-42552-JX1A/10801902193275/33F25D0561, 33F24L0285; CDC-42563-JX1A/10801902193275, 10801902170863/33F25C0702, 33F25D0562, 33F25G0311, 33F25J0437, 33F24D0507; CDC-43052-JX1A/10801902193275/33F25M0062, 33F24J0120; CDC-43063-JX1A/10801902193275, 10801902188332/33F25G0003, 33F26B0805, 33F25D0240; CDC-05542-PK1A/10801902193275, 50801902116715/33F25H0436, 33F25H0576, 33F24D0325

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 17 of 35

Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 15 CM/CDC-41552-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 15 CM/CDC-41563-JX1A; AGBA PI JACC KIT: 1-L 4.5 FR X 20 CM/CDC-42041-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 20 CM/CDC-42052-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 20 CM/CDC-42063-JX1A

Z-2379-2026

Recall number: Z-2379-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 1,516

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): ASK-41552-LTAC/10801902193275/33F24J0142, 33F24H0002; ASK-42063-LTAC/10801902214925/33F24F1005; CDC-41541-JX1A/10801902193275/33F25H0768; CDC-41552-JX1A/10801902193275, 10801902201505/33F25A0185, 33F25E0826, 33F24D0561; CDC-41563-JX1A/10801902193275/33F25B0150; CDC-42041-JX1A/10801902193275, 10801902188288/33F25E0751, 33F26C0353, 33F25A0186; CDC-42052-JX1A/10801902193275/33F25G0312, 33F24J0131; CDC-42063-JX1A/10801902193275/33F25C0447, 33F25D0516, 33F25E0752, 33F25J0436, 33F25C0370

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 18 of 35

Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000

Z-2380-2026

Recall number: Z-2380-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 7560

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): AK-09000/30801902121722, 10801902193275, 20801902121756/33F24B0178, 33F24C0097, 33F24E0336, 33F24F0311, 33F24G0335, 33F24K0101, 33F24L0795, 33F25E0919, 33F25G0467, 33F25G0758, 33F25H0722, 33F25J0468, 33F25L0463, 33F26A0389, 33F24A0368

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 19 of 35

Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F

Z-2381-2026

Recall number: Z-2381-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 1,945

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): AK-12122-F/10801902197129, 10801902193275, 10801902197129, 10801902168464/33F24B0184, 33F24D0076, 33F24F0321, 33F24G0345, 33F24K0111, 33F25A0474, 33F25C0915, 33F25E0061, 33F25E0924, 33F25J0832, 33F25L0404, 33F26B0552, 33F24A0102

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 20 of 35

Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T, THORACENTESIS KIT/AK-01000, THORACENTESIS KIT/ASK-01000-CHP, DRAINAGE KIT/ASK-01000-NW, THORACENTESIS KIT/ASK-01000-UPMS, PNEUMOTHORAX KIT/AK-01500, PNEUMOTHORAX KIT (NO HEIMLICH VALVE)/ASK-01500, PNEUMOTHORAX KIT/ASK-01500-JCM

Z-2382-2026

Recall number: Z-2382-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 444,943

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): AK-01600/50801902120156, 10801902193275, 50801902120156, 60801902120160/33F24A0376, 33F24A1008, 33F24C0091, 33F24D0067, 33F24E0321, 33F24G0322, 33F24L0062, 33F24L0811, 33F24M0267, 33F25C0101, 33F25C0988, 33F25E0035, 33F25H0010, 33F25J0819, 33F26B0492, 33F24A0044; AK-01601/60801902120160, 10801902193275, 10801902190915/33F24A0783, 33F24A1070, 33F24C0092, 33F24E0322, 33F24G0323, 33F24J0273, 33F24L0651, 33F25C0102, 33F25C0916, 33F25E0036, 33F25G0078, 33F25J0460, 33F25L0371, 33F24B0427; ASK-01601-MM/10801902125726, 10801902193275, 10801902125726, 10801902205909/33F24F0656, 33F24K0319, 33F24M0166, 33F25A0163, 33F25E0587, 33F25G0164, 33F25L0116, 33F26A1377, 33F26C0174, 33F24F0213; AK-01000-T/10801902145120, 10801902193275, 10801902194029/33F24C0090, 33F24D0066, 33F24E0319, 33F24G0320, 33F24K0085, 33F24L0792, 33F25C0872, 33F25E0033, 33F25J0459, 33F25L0367, 33F24A0015; AK-01000/10801902197952, 10801902193275, 10801902197952, 10801902145120/33F24A0017, 33F24A0018, 33F24A0348, 33F24A0349, 33F24A0350, 33F24A0351, 33F24A1005, 33F24A1006, 33F24D0005, 33F24D0006, 33F24D0007, 33F24D0008, 33F24D0009, 33F24D0010, 33F24D0011, 33F24D0012, 33F24E0032, 33F24E0033, 33F24E0034, 33F24E0035, 33F24E0036, 33F24E0037, 33F24E0038, 33F24E0041, 33F24E0042, 33F24E0167, 33F24E0168, 33F24E0169, 33F24E0170, 33F24E0171, 33F24G0319, 33F24G0567, 33F24G0568, 33F24J0487, 33F24J0673, 33F24K0084, 33F24K0308, 33F24K0312, 33F24L0626, 33F24L0726, 33F24L0782, 33F24L0787, 33F25A0454, 33F25A0611, 33F25A0612, 33F25C0100,33F25C0211,33F25C0905,33F25C0954, 33F25E0032,33F25E0286, 33F25E0287, 33F25E0908, 33F25E1063, 33F25E1064, 33F25G0076, 33F25G0157, 33F25H0008, 33F25H0188, 33F25H0189, 33F25H0190, 33F25H0191, 33F25H0192, 33F25J0458, 33F25J0740, 33F25J0741, 33F25J0788, 33F25J0799, 33F25J0800, 33F25K0250, 33F25K0251, 33F25K0360, 33F25K0361, 33F25K0362, 33F25K0363, 33F25L0019, 33F25L0020, 33F25L0100, 33F25L0101, 33F25L0268, 33F25L0485, 33F25L0487, 33F25M0831, 33F25M0860, 33F26A0217, 33F26A0218, 33F26A0693, 33F26A0988, 33F26B0505, 33F26B0506, 33F26C0574, 33F24A0794; ASK-01000-CHP/10801902193275, 30801902120190, 10801902203134/33F24G0228, 33F24J0192, 33F24K0020, 33F24L0021, 33F24L0523, 33F24M0063, 33F25B0010, 33F25B0061, 33F25B0132, 33F25C0405, 33F25D0198, 33F25H0277, 33F25H0810, 33F25J0995, 33F26A1273, 33F26B0695, 33F24E0388; ASK-01000-NW/10801902193275, 10801902114867/33F24G0390, 33F24K0153, 33F25B0693, 33F25C0873, 33F25H0051, 33F25J0854, 33F25M0921, 33F24A0645; ASK-01000-UPMS/10801902114867, 10801902193275/33F24B0805, 33F24C0930, 33F24D0683, 33F24H0186, 33F24L0214, 33F24L0912, 33F25B0542, 33F25D0325, 33F25D0527, 33F25F0156,33F25J0099, 33F25J0196, 33F25L0270, 33F26A1392, 33F24G0276; AK-01500/10801902194029, 10801902193275, 50801902120156/33F24E0044, 33F24E0172, 33F24E0173, 33F24G0321, 33F24G0569, 33F24J0488, 33F24K0086, 33F24K0573, 33F24L0724, 33F25A0455, 33F25C0722, 33F25D0126, 33F25E0034, 33F25E0909, 33F25G0077, 33F25G0549, 33F25H0009, 33F25H0720, 33F25J0818, 33F25L0384, 33F26B0535, 33F26C0263, 33R24E0044, 33F23K0711; ASK-01500/10801902156232, 10801902193275, 30801902120206/33F24A0777, 33F24C0130, 33F24E0391, 33F24G0392, 33F24J0542, 33F24L0765, 33F25C0127, 33F25C0735, 33F25E0105, 33F25H0053, 33F25J0495, 33F25L0335, 33F24A1274; ASK-01500-JCM/30801902120206, 10801902193275, 10801902125726

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 21 of 35

Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU

Z-2383-2026

Recall number: Z-2383-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 95

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): ASK-07155-MGU/10801902210217/33F25C0798

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 22 of 35

Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-12703-PSPH1; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-WMC2; MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDT1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDTG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-15703-PVH; 1L CVC KIT: 16 GA X 8 IN (20CM)/ASK-24301-JHH1; CVC KIT: 16 GA X 16 CM/CDC-24306-1A; CVC KIT: 3-L 7 FR X 30 CM ANTIMICROBIAL/CDC-24703-X1A; LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-1A; CVC KIT: 2L 8 FR X 6IN (16 CM)/ASK-42802-ECL3; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-ACH; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-BJC1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-DU1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-EMC; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6IN/ASK-42703-LMDT1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-LMDTG1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-MCY1; MULTILUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-NS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAGP1; PI CVC KIT: 3L 7 FR X 6 IN (16 CM)/ASK-42703-PAM1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAMC2; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAU1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16/ASK-42703-PB1; PI CVC KIT: 3L 7 FR X 16CM AGB+/ASK-42703-PBSWH2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 IN/ASK-42703-PCAM1; MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-PCSJ2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PECL2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PGM4; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHHN1; MULTI LUMEN CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PLC; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMEM; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMHC1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-POHU2; MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU2; MULTILUMEN CVC KIT 7 FR X 6 IN (16 CM)/ASK-42703-PTJH; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUCH2; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-PUCI1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUHC2; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUMH; MULTI-LUMEN PI CVC KIT: 3-L 7 FR/ASK-42703-PUPM1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-SHUF2; MULTI LUMEN PI CVC KIT: 3L 7 FR/ASK-42703-SL1; CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-42703-UMC; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-WHH; CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-CHM; CVC KIT: 2L 8 FR X 16 CM/ASK-42802-LMDT1; PI CATHETER 2L: 8FR X 16CM AGB+/ASK-42802-MCY1; PI CVC KIT: 2L 8FR X 16CM AGB+/ASK-42802-PBSWH2; MULTILUMEN CVC KIT: 2L 8 FR X 6/ASK-42802-POSU2; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PUNCC2; PI CVC KIT: 2-L 8 FR/ASK-42802-PUPM1; PI CVC KIT: 2L 8 FR/ASK-42802-TGH1; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-BJC1; CVC KIT: 4L 8.5 FR X (16CM) AGB+/ASK-42854-PBMH; PI CVC KIT: 4L 8.5FR X 16CM AGB+/ASK-42854-PMM; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-PUCH2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-ACH; 3L CVC KIT: 7 FR X 20 CM AGB+/ASK-45703-ARM; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-BJC1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-BLH; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-DU1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-HHC4; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-LMDT1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-LMDTG1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-MCY1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-NO; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-NS1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PADV1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PAGP1; MULTI LUMEN CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PAMC1; MULTI LUMEN CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PAU1; PI CVC KIT: 3L 7FR X 20CM AGB+/ASK-45703-PBSWH2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PCAM1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PCSJ2; PI CVC KIT: 3L 7 FR X 8 IN (20 CM) AGB+/ASK-45703-PDM1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PECL2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/A

Z-2384-2026

Recall number: Z-2384-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 1,061,069

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): ASK-04001-JHH/10801902193275/33F24K0748, 33F26A1669, 33F25G0558; ASK-04001-LMDTG/10801902193275, 10801902218442/33F26A0405, 33F24E0333; ASK-12703-PSPH1/10801902214338, 10801902193275, 10801902214338/33F24F0787, 33F24L0304, 33F25A0242, 33F25C0268, 33F25D0470, 33F25E0537, 33F25E0854, 33F25J0365, 33F25M0247, 33F26A1555, 33F26B0855, 33F26C0742, 33F24K0672; ASK-12703-WMC2/10801902193275/33F24K0493, 33F24L0305, 33F25B0156, 33F25E0593, 33F25H0483, 33F25J0367, 33F25M0218, 33F24K0545; ASK-15703-LMDT1/10801902193275/33F24J0164, 33F24L0307, 33F25B0192, 33F25C0230; ASK-15703-LMDTG1/10801902193275/33F25D0537, 33F25E0670, 33F25G0295, 33F25J0146, 33F25K0093, 33F25M0138, 33F26B0131, 33F25E0312; ASK-15703-PVH/10801902133226, 10801902193275, 10801902210217/33F24D0809, 33F24F0669, 33F24K0462, 33F24L0226, 33F25A0167, 33F25B0193, 33F25B0547, 33F25D0265, 33F25D0653, 33F25G0169, 33F25G0404, 33F25J0369, 33F26A1459, 33F24M0270; ASK-24301-JHH1/10801902193275, 10801902214819, 10801902210217/33F25A0170, 33F25B0552, 33F25E0547, 33F25G0222, 33F25L0056, 33F26B0421, 33F24E0546; CDC-24306-1A/30801902116919, 10801902193275, 30801902116919/33F24D0786, 33F24E0620, 33F24F0926, 33F24K0446, 33F24L0990, 33F25A0310, 33F25D0495, 33F25E0880, 33F25J0323, 33F26B0377, 33F26C0693, 33F24L1111; CDC-24703-X1A/10801902193275/33F25D0497, 33F25E0748, 33F25G0318, 33F25H0570, 33F25J0325, 33F26A1563, 33F25B0619; CDC-25123-1A/10801902193275, 10801902191622/33F24H0012, 33F24L0481, 33F25C0445, 33F25D0500, 33F25F0382, 33F25G0258, 33F26A1560, 33F26B0394, 33F25B0675; ASK-42802-ECL3/10801902193275/33F25E0567, 33F25F0128, 33F25H0464, 33F25J0286, 33F26A1399; ASK-42703-ACH/10801902193275, 30801902119514/33F24L0327, 33F24L1064, 33F25C0292, 33F25E0675, 33F25H0420, 33F25J0267, 33F25L0122, 33F25M0091, 33F26A1505, 33F24D0032; ASK-42703-BJC1/10801902193275, 10801902202519/33F24K0500, 33F24L0328, 33F25B0556, 33F25G0173, 33F25J0268, 33F26A1513, 33F26B0767, 33F25C0744; ASK-42703-DU1/10801902193275, 1080190216099/33F25B0141, 33F25C0232, 33F25E0786, 33F25J0105, 33F25M0014, 33F26C0342, 33F24F0060; ASK-42703-EMC/10801902160475, 10801902118421/33F24F0881, 33F25A0214, 33F25C0293, 33F25D0596, 33F25H0632, 33F25M0115, 33F26C0343, 33F24F0132; ASK-42703-LMDT1/10801902205657, 10801902193275/33F24F0688, 33F24J0157, 33F24L0228, 33F24L0329, 33F24L1096, 33F25A0252, 33F25B0557, 33F25C0352, 33F25E0557, 33F25E0722, 33F25G0400, 33F25K0139, 33F26A1370, 33F26B0210, 33F25C0294; ASK-42703-LMDTG1/10801902193275, 10801902205695, 10801902220896/33F25E0558, 33F25E0860, 33F25G0271, 33F25G0399, 33F25H0419, 33F26B0387, 33F24G0070; ASK-42703-MCY1/10801902193275, 0801902220896/33F24H0198, 33F24K0425, 33F25A0198, 33F25B0651, 33F25C0353, 33F25D0405, 33F25E0676, 33F25H0452, 33F25J0220, 33F25M0183, 33F26A1479, 33F26B0863, 33F25H0409; ASK-42703-NS1/10801902193275, 10801902216479/33F25A0300, 33F25B0652, 33F25C0375, 33F25E0723, 33F25H0459, 33F25J0221, 33F26A1579, 33F26B0825, 33F25C0354; ASK-42703-PAGP1/10801902193275, 10801902158717, 10801902136685/33F25D0406, 33F25E0560, 33F25E0790, 33F25H0560, 33F25L0114, 33F26A1353, 33F26A1506, 33F26B0751, 33F24D0181; ASK-42703-PAM1/10801902136685, 10801902193275/33F24E0310, 33F24L0895, 33F25A0256, 33F25B0496, 33F25C0477; ASK-42703-PAMC2/10801902193275, 10801902217131/33F25F0188, 33F25J0270, 33F26C0161, 33F24K0400; ASK-42703-PAU1/10801902193275/33F24L0414, 33F25B0143, 33F25C0474, 33F25G0397, 33F25M0313, 33F26A1349, 33F25B0232; ASK-42703-PB1/10801902193275, 10801902220377/33F25E0458, 33F25K0427, 33F24F0065; ASK-42703-PBSWH2/10801902220377, 10801902193275, 10801902220377, 10801902203189/33F24F0651, 33F24K0368, 33F24L0230, 33F24L0415, 33F24L1079, 33F25B0167, 33F25C0440, 33F25D0539, 33F25E0014, 33F25E0596, 33F25G0205, 33F25H0511, 33F25J0222, 33F25K0112, 33F25M0394, 33F26B0412, 33F24D0720; ASK-42703-PCAM1/10801902203189, 10801902193275, 10801902141030/33F24F0675, 33F24L1058, 33F25B0560, 33F25C0355, 33F25D0351, 33F25E0725, 33F25G0366, 33F25J0386, 33F25M0388, 33F26B0791, 33F24F0874; ASK-42703-PCSJ2/10801902193275, 10801902211672/33F25H0468, 33F25J0271, 33F26B0389, 33F26C0179, 33S24L0906, 33F25B0445; ASK-42703-PECL2/10801902193275/33F25H0466, 33F25J0272, 33F26A0011; ASK-42703-PGM4/10801902193275, 10801902221824/33F25B0653, 33F25D0541, 33F25J0106, 33F25J0387, 33F25K0140, 33F26B0749, 33F26C0027, 33F25E1195; ASK-42703-PHHN1/10801902193275, 10801902144734/33F25H0486, 33F25K0064, 33F25M0673, 33F26A0249, 33F26B0906, 33F25E0009; ASK-42703-PLC/10801902193275/33F25D0407, 33F25E0791, 33F25F0099, 33F25H0606, 33F26A1393, 33F25E1196; ASK-42703-PMEM/10801902193275, 10801902142167/33F25G0554, 33F25K0054, 33F25L0256, 33F26C0050, 33F24L0418; ASK-42703-PMHC1/10801902193275/10801902135244/33F25E0561, 33F25H0430, 33F25H0638, 33F25J0388, 33F25M0232, 33F26B0135, 33F26B0796, 33F25F0363; ASK-42703-PNHS1/10801902193275, 10801902225495/33F25D0542, 33F25E0599, 33F25H0498, 33F25H0650, 33F26D0066; ASK-42703-POHU2/10801902193275, 10801902212020/33F25E0562, 33F25G0284, 33F25J0389, 33F26A1421, 33F24F0662; ASK-42703-POSU2/10801902193275/33F24K0401, 33F24L0419, 33F24L0949, 33F25B0446, 33F25D0758; ASK-42703-PTJH/10801902193275, 10801902219012/33F24L0190, 33F25A0015, 33F25B0366, 33F25C0658, 33F25E0316, 33F24E0660; ASK-42703-PUCH2/10801902219012, 10801902193275, 10801902219012, 10801902135022/ ASK-42703-PUCI1/33F24F1025, 33F24L0336, 33F24L1009, 33F25B0476, 33F25C0356, 33F25E0021, 33F25F0189, 33F25H0455, 33F25J0275, 33F25K0142, 33F25M0120, 33F26A1518, 33F26B0182, 33F26B0781, 33F24F0850; ASK-42703-PUHC2/10801902193275, 10801902159608/33F25D0353, 33F25E0602, 33F25G0288, 33F25H0635, 33F25J0277, 33F25K0143, 33F26B0386, 33F26C0149, 33F24D0765; ASK-42703-PUMH/10801902129465, 10801902193275, 10801902159592/33F24F0697, 33F24K0709, 33F24L0997, 33F25C0301, 33F25E0677, 33F25J0278, 33F26A0256, 33F26B0789, 33F26C0227, 33F24D0698; ASK-42703-PUPM1/10801902159592, 10801902193275, 10801902225150/33F24F0761, 33F24K0499, 33F24L1074, 33F25B0519, 33F25C0357, 33F25D0354, 33F25D0598, 33F25E0678, 33F25G0346, 33F25J0279, 33F25M0126, 33F26B0363; ASK-42703-SHUF2/10801902193275, 10801902208368/33F25D0355, 33F25E0792, 33F25H0473, 33F25J0280, 33F25M0204, 33F26A1501, 33F26B0832, 33F24L0339; ASK-42703-SL1/10801902193275, 10801902205206/33F25B0483, 33F25C0443, 33F25D0482, 33F25E0793, 33F25G0306, 33F25J0281, 33F26A1437, 33F24D0631; ASK-42703-UMC/10801902193275, 10801902205206/33F24K0363, 33F24L0340, 33F25B0568,33F25E0801, 33F25G0328, 33F25J0282, 33F25M0194, 33F26A1444, 33F26B0769, 33F26C0221, 33F25B0158; ASK-42703-WHH/10801902193275, 10801902159189, 30801902119576/33F25E0565, 33F25G0350, 33F25J0283, 33F26B0777, 33F24E0552; ASK-42802-CHM/10801902193275/33F24H0178, 33F24K0480, 33F24L0859, 33F25D0236, 33F25F0190, 33F25H0518, 33F25J0284, 33F25M0139, 33F26B0175, 33F25E0005; ASK-42802-LMDT1/10801902205664, 10801902193275/33F24F0737, 33F24K0381, 33F24L0250, 33F24L0423, 33F25B0570, 33F25C0377, 33F25F0129, 33F25G0281, 33F25J0158, 33F25K0146, 33F26C0156, 33F25F0533; ASK-42802-MCY1/10801902193275, 10801902220384/33F24K0328, 33F24K0754, 33F24F0964; ASK-42802-PBSWH2/10801902193275, 10801902220384/33F24H0200, 33F24K0408, 33F24L0424, 33F24L1006, 33F25B0477, 33F25D0357, 33F25G0203, 33F25G0204, 33F25H0659, 33F25J0390, 33F25M0195, 33F25M0335, 33F26B0424, 33F24F0759; ASK-42802-POSU2/10801902193275/33F24K0473, 33F25D0759; ASK-42802-PUNCC2/10801902164251, 10801902193275, 10801902159585/33F24F0948, 33F24L0425, 33F25H0443, 33F25J0394, 33F24D0660; ASK-42802-PUPM1/10801902159585, 10801902193275, 10801902225143/33F24F0668, 33F24K0422, 33F24L0341, 33F24L1042, 33F25C0305, 33F25E0679, 33F25F0194, 33F25J0159, 33F25M0123, 33F26B0364; ASK-42802-TGH1/10801902213829, 10801902193275, 10801902213829/33F24L1054, 33F25B0521, 33F25D0311, 33F25E0604, 33F25G0225, 33F25J0288, 33F25L0204, 33F26A1543, 33F26B0844, 33F26C0224, 33F25C0306; ASK-42854-BJC1/10801902202540, 10801902193275, 10801902202540/33F24F0644, 33F24K0348, 33F24L0232, 33F25A0260, 33F25B0571, 33F25D0358, 33F25D0601, 33F25E0863, 33F25G0367, 33F26A1524, 33F26B0764, 33F26C0140, 33F24H0126; ASK-42854-PBMH/10801902193275, 40801902131469/33F26A0241, 33F24E0639; ASK-42854-PMM/40801902131469, 10801902193275/33F24F1014, 33F24L1013, 33F25C0307, 33F25D0546, 33F25E0802, 33F25H0480, 33F25J0398, 33F25A0019; ASK-42854-PUCH2/10801902193275, 10801902219050/33F25K0065, 33F26B0902, 33F24L0347; ASK-45703-ACH/10801902193275, 10801902203257, 30801902119644/33F25B0235, 33F25E0007, 33F25F0237, 33F25K0046, 33F25M0675, 33F26B0221, 33F24D0033; ASK-45703-ARM/10801902193275, 1080190215812/33F24L0903, 33F25B0449, 33F25D0363, 33F25E0682, 33F25H0479, 33F25J0228, 33F25K0150, 33F26A1423, 33F26B0849, 33F25F0004; ASK-45703-BJC1/10801902193275, 10801902202533, 10801902213782/33F24K0426, 33F24L0826, 33F25B0450, 33F25B0577, 33F25D0547, 33F25F0104, 33F25F0199, 33F25M0096, 33F26A1348, 33F26B0378, 33F26B0750, 33F24F0776; ASK-45703-BLH/10801902193275, 10801902213782, 10801902135381/33F24L1067, 33F25J0110, 33F25K0071, 33F25K0151, 33F25M0331, 33F26A1457, 33F26B0776, 33F24F0165; ASK-45703-DU1/10801902193275, 10801902160970, 10801902160468/33F25B0451, 33F25D0548, 33F25E0683, 33F25H0558, 33F26A1451, 33F26B0208, 33F26B0707, 33F26B0845, 33F24D0579; ASK-45703-HHC4/10801902193275, 10801902211467, 10801902205671/33F25D0364 ,33F25D0661, 33F25E0867, 33F25G0246, 33F25H0598, 33F25J0229, 33F25M0152, 33F26A1537, 33F26B0818, 33S25E0867, 33F24F0873; ASK-45703-LMDT1/10801902193275, 10801902205671/33F24K0440, 33F24L0432, 33F24L0919, 33F25B0160, 33F25D0365, 33F25D0603, 33F25E0608, 33F25G0326, 33F25H0475, 33F25J0230, 33F25M0153, 33F26A1552, 33F26B0880, 33F25B0453; ASK-45703-LMDTG1/10801902193275, 10801902205749, 10801902220902/33F25B0579, 33F25E0018, 33F25E0609, 33F25F0200, 33F25G0398, 33F25J0401, 33F25M0190, 33F25M0332, 33F26B0482, 33F26C0226, 33F24G0072; ASK-45703-MCY1/10801902193275/33F24J0132, 33F24K0445, 33F24L0433, 33F24L1028, 33F25B0657, 33F25E0022, 33F25E0610, 33F25F0201, 33F25H0657, 33F25M0144, 33F26A1573, 33F25L0143; ASK-45703-NO/10801902205213, 10801902193275, 10801902216417/33F24F0844, 33F24L0352, 33F25B0581, 33F25E0611, 33F24D0769; ASK-45703-NS1/10801902216417, 10801902193275, 10801902216417/33F24F0835, 33F24L0434, 33F24L1047, 33F25E0612, 33F25F0130, 33F25G0214, 33F25M0176, 33F26A1544, 33F26B0864, 33F25F0006; ASK-45703-PADV1/10801902193275/33F24J0146, 33F24K0458, 33F24L0353, 33F25C0311, 33F25E0423, 33F25E0684, 33F25H0561, 33F25M0127, 33F26A0775, 33F25A0265; ASK-45703-PAGP1/10801902193275, 10801902158724/33F25E0613, 33F25F0202, 33F25G0409, 33F25J0297, 33F26A1339, 33F26C0125, 33F25B0658; ASK-45703-PAMC1/10801902193275, 10801902217148, 10801902208344/33F25D0549, 33F25E0728, 33F25J0298, 33F25K0152, 33F26B0199, 33F24D0738; ASK-45703-PAU1/10801902208344, 10801902193275, 10801902220353/33F24F0783, 33F24L0354, 33F25D0483, 33F25E0729, 33F25H0534, 33F25J0404, 33F24F0070; ASK-45703-PBSWH2/10801902220353, 10801902193275, 10801902220353, 10801902203158/33F24F0937, 33F24L0437, 33F24L1112, 33F25A0306, 33F25B0659, 33F25E0614, 33F25E0803, 33F25F0080, 33F25H0368, 33F25H0513, 33F25K0153, 33F25M0191, 33F26C0157, 33F24F0660; ASK-45703-PCAM1/10801902193275/33F24L0355, 33F25C0312, 33F25E0016, 33F25E0804, 33F25J0162, 33F26A1447, 33F24K0479; ASK-45703-PCSJ2/10801902193275, 10801902211689, 10801902202861/33F25G0245, 33F25J0165, 33F25K0155, 33F26A1546, 33F26B0853, 33F24D0896; ASK-45703-PDM1/10801902202861, 10801902193275/33F24F0747, 33F25A0268, 33F25B0584, 33F25D0368, 33F25D0604, 33F25E0617, 33F25G0330, 33F25H0612, 33F25J0166, 33F25M0196, 33F26A1460, 33F25B0585; ASK-45703-PECL2/10801902193275/33F25D0369, 33F25D0605, 33F25E0619, 33F25G0242, 33F25J0168, 33F26A0013; ASK-45703-PGM4/10801902193275, 10801902221817/33F25B0660, 33F25D0412, 33F25J0169, 33F25K0078, 33F26C0176, 33F24M0174; ASK-45703-PGVH/10801902193275, 10801902200508/33F25E0310, 33F25H0781, 33F24F0101; ASK-45703-PHF4/)10801902200508, 10801902193275/33F24F0887, 33F24L0253, 33F24L0439, 33F25A0269, 33F25B0586, 33F25C0314, 33F25D0606, 33F25E0575, 33F25F0118, 33F25M0060, 33F25M0170, 33F26A1480, 33F26B0877, 33F25B0587; ASK-45703-PHUMC1/10801902193275, 10801902201017/33F25K0047, 33F25L0137, 33F26C0116, 33F25B0588; ASK-45703-PJHH1/10801902214833, 10801902193275/33F24D0929, 33F24F0765, 33F24L0254, 33F25B0162, 33F25B0589, 33F25E0013, 33F25E0023, 33F25E0622, 33F25G0223, 33F25J0171, 33F26A1461, 33F26B0798, 33F26C0195, 33F25A0271; ASK-45703-PMEM/10801902142174, 10801902193275/33F26C0051, 33F25B0591; ASK-45703-PMHC1/10801902193275, 10801902135237/33F25D0485, 33F25F0146, 33F25H0562, 33F25K0405, 33F26A1462, 33F26B0871, 33F25A0272; ASK-45703-PNHS1/10801902193275, 10801902193275/33F25C0317, 33F25E0732, 33F25G0293, 33F25H0649, 33F26D0067; ASK-45703-PNO2/10801902193275, 10801902205220, 10801902212082/33F25E0685, 33F25H0536, 33F25K0073, 33F25K0157, 33F26A1373, 33F26B0154, 33F26C0006, 33F24F0731; ASK-45703-POSU2/10801902193275/33F24K0404, 33F24L0868, 33F25B0457, 33F25B0594, 33F25D0760; ASK-45703-PPHPB1/10801902143850, 10801902193275/33F24F0721, 33F24K0379, 33F24L0444, 33F24L0849, 33F25B0595, 33F25D0487, 33F25E0805, 33F25H0496, 33F25J0299, 33F25K0158, 33F25E0444; ASK-45703-PRGK1/10801902193275, 10801902136654/33F25E0577, 33F25E0806, 33F25G0267, 33F25G0353, 33F25J0300, 33F26A1439, 33F26B0865, 33F24L0869; ASK-45703-PSAU1/10801902193275, 10801902159462/33F25L0262, 33F26C0049, 33F24H0106; ASK-45703-PSCH1/10801902193275/33F25B0241, 33F25E0010, 33F25H0777, 33F24M0274; ASK-45703-PSFR1/10801902193275/33F25H0451, 33F25H0654, 33F25M0145, 33F26A1540, 33F25C0483; ASK-45703-PSHS2/10801902193275/33F25E0808, 33F25H0517, 33F24L0873; ASK-45703-PSJR1/10801902193275, 10801902221053, 10801902125207/33F25D0371, 33F25E0625, 33F25G0198, 33F25M0162, 33F26C0128, 33F24F0626; ASK-45703-PSSM1/10801902193275, 10801902119749/33F24K0571, 33F25A0022, 33F25A0432, 33F25B0231, 33F25B0436, 33F25C0656, 33F25G0556, 33F26A0245, 33F24D0917; ASK-45703-PUCH2/10801902219029, 10801902193275, 10801902135046/33F24F0960, 33F24L0447, 33F24L1029, 33F25C0362, 33F25E0734, 33F25H0661, 33F25M0171, 33F26A1527, 33F26B0763, 33F24D0665; ASK-45703-PUCI1/10801902193275, 10801902135046/33F24J0172, 33F24L0363, 33F25B0460, 33F25C0321, 33F25E0626, 33F25F0205, 33F25J0304, 33F25M0187, 33F26C0013, 33F24L0971; ASK-45703-PUHC2/10801902193275, 10801902159615, 10801902118674/33F25A0277, 33F25E0627, 33F25G0302, 33F25J0232, 33F25M0119, 33F26B0128, 33F26B0879, 33F24D0730; ASK-45703-PUMC/10801902193275, 10801902113228/33F25C0322, 33F25E0688, 33F25H0648, 33F25M0122, 33F26B0130, 33F25F0376; ASK-45703-PUMH/10801902193275, 10801902129489, 10801902156355/33F25A0010, 33F25D0029, 33F25G0009, 33F25K0055, 33F25L0257, 33F26C0118, 33F24D0694; ASK-45703-PUN1/10801902156355, 10801902193275, 10801902164268/33F24F0769, 33F24L0948, 33F25B0462, 33F25C0323, 33F25E0689, 33F25M0131, 33F26C0130, 33F24D0696; ASK-45703-PUNMH/10801902193275, 10801902144161, 10801902159554/33F24L0264, 33F24L0366, 33F25B0599, 33F25D0374, 33F25E0691, 33F25G0305, 33F25J0406, 33F25K0161, 33F25M0222, 33F26B0716, 33F26B0870, 33F24D0848; ASK-45703-PUPM1/10801902159554, 10801902193275, 10801902159554, 10801902225181/33F24F0689, 33F24L0265, 33F24L1128, 33F25A0278, 33F25B0600, 33F25C0324, 33F25E0629, 33F25E0869, 33F25G0408, 33F25H0633, 33S25E0869,, 33F26B0365; ASK-45703-PUWH/10801902193275, 10801902112948/33F24M0046, 33F25A0023, 33F25A0429, 33F25E1174, 33F25G0266, 33F25H0779, 33F25K0049, 33F25L0131, 33F26A1132, 33F24D0310; ASK-45703-PVCU1/10801902112948, 10801902193275/33F24D0869, 33F24L0451, 33F24L0924, 33F25B0602, 33F25D0552, 33F25F0131, 33F25G0304, 33F25J0305, 33F26B0797, 33F25B0463; ASK-45703-PWH1/10801902213904/33F24E0561; ASK-45703-PYNH1/10801902193275/33F24G0519, 33F24K0268, 33F25C0184, 33F25C0909, 33F25E0244, 33F25L0336, 33F25M0843, 33F25G0261; ASK-45703-RR/10801902206944, 10801902193275/33F24F0961, 33F24K0447, 33F24L0452, 33F24L0879, 33F25B0603, 33F25D0608, 33F25E0871, 33F25K0087, 33F25M0395, 33F26A1425, 33F26A1426, 33F26C0695, 33F25B0604; ASK-45703-SHUF2/10801902193275, 10801902208351, 10801902202366/33F25E0631, 33F25F0206, 33F25G0396, 33F25J0174, 33F26B0778, 33F24F0771; ASK-45703-SL1/10801902193275, 10801902202366, 10801902203127/33F24L0453, 33F25B0464, 33F25D0413, 33F25E0809, 33F25H0538, 33F25J0409, 33F26A1410, 33F26B0173, 33F24D0583; ASK-45703-TC/10801902203127, 10801902193275/33F24F0877, 33F24L0454, 33F25B0146, 33F25H0539, 33F26B0186, 33F24L0163; ASK-45854-BJC1/10801902193275, 10801902202557/33F24L0164, 33F24L1019, 33F25B0605, 33F25E0810, 33F26C0137, 33F25B0465; ASK-45854-LMDTG1/10801902193275, 10801902205763/33F25D0376, 33F25D0662, 33F25E0735, 33F25H0535, 33F25J0411, 33F26A1409, 33F26C0126, 33F24H0216; ASK-45854-MCY1/10801902193275/33F24K0494, 33F25L0145; ASK-45854-PBMH/10801902193275/33F25M0676, 33F24L0456; ASK-45854-PBSWH2/10801902193275, 10801902220360/33F25A0307, 33F25C0364, 33F25E0736, 33F25H0512, 33F25J0412, 33F26B0788, 33F25B0606; ASK-45854-PECL2/10801902193275, 10801902224269/33F25K0056, 33F25M0678, 33F26B0227; ASK-45854-PNHS1/10801902193275, 10801902225471/33F25C0326, 33F25D0489, 33F25J0235, 33F26A1351, 33F26D0065; ASK-45854-PPHPB1/10801902193275/33F24H0170, 33F24L0370, 33F25B0607, 33F25C0475, 33F25E0692, 33F25H0581, 33F25J0306, 33F25D0031; ASK-45854-PSHS2/10801902193275/33F25F0371, 33F25K0062, 33F25M0679; ASK-45854-PUN1/10801902193275, 10801902159578/33F25H0484, 33F24D0717; ASK-45854-PUPM1/10801902159578, 10801902193275, 10801902225167/33F24E0665, 33F24F0898, 33F24L1007,33F25B0163, 33F25B0608, 33F25D0414, 33F25E0811, 33F25H0559, 33F25M0011, 33F26B0366; ASK-45854-PUR1/10801902193275/33F24M0178, 33F25B0429, 33F25E1200, 33F25K0057, 33F26A0250, 33F26A1394; ASK-46702-PJHH1/10801902193275, 10801902214888, 10801902116700/33F24L0835, 33F25D0490, 33F25J0307, 33F26C0351, 33F24F1020; CDC-42854-XPCN1A/10801902162134, 10801902193275/33F24F0702, 33F24K0345, 33F24L0130,33F24L0387,33F24L1147, 33F25B0631, 33F25C0334, 33F25D0565, 33F25E0703, 33F25E0897, 33F25G0344, 33F25J0254, 33F26A1476, 33F26B0897, 33F26C0067, 33F25B0534; CDC-42854-XPN1A/10801902193275, 10801902162141/33F25C0335, 33F25D0566, 33F25D0673, 33F26B0810, 33F26B0944, 33F24J0098; CDC-45854-XPCN1A/10801902162158, 10801902193275/33F24E0224, 33F24F0217, 33F24F0245, 33F24G0110, 33F24H0071, 33F24H0430, 33F24J0227, 33F24M0059, 33F24M0117, 33F25A0370, 33F25B0320, 33F25E1128, 33F25F0014, 33F25G0068, 33F25H0291, 33F25J0620, 33F25J0977, 33F25L0089, 33F26A1621, 33F26A1631, 33F26B0625, 33F25A0319; CDC-45854-XPN1A/10801902193275, 10801902162165/33F25B0633, 33F25C0336, 33F25D0572, 33F25E0758, 33F25G0259, 33F25G0342, 33F25J0331, 33F26A0419, 33F26A1569, 33F26C0215, 33F25B0634; AK-42703-CDC/10801902193275/33F25C0802, 33F25H0042, 33F25J0849, 33F25L0415, 33F25B0538; AK-45703-ACDC/10801902167825, 10801902193275, 10801902167825/33F24C0123, 33F24E0379, 33F24G0382, 33F24J0536, 33F24K0144, 33F24L0547, 33F24L1161, 33F25A0490, 33F25C0824, 33F25E0093, 33F25E0949, 33F25G0756, 33F25H0043, 33F25J0489, 33F25L0418, 33F25M0677, 33F26A1054, 33F26A1256, 33F26B0561, 33F26B0976, 33F25B0513; CDC-42703-P1A/10801902170863, 10801902193275/33F24D0984,33F24E0263, 33F24E0840, 33F24F0157, 33F24F0174, 33F24F0234, 33F24H0403, 33F24H0437, 33F24H0459, 33F24J0255, 33F24K0045, 33F24M0042, 33F24M0078, 33F24M0136, 33F25A0386, 33F25B0048, 33F25B0120, 33F25C0220, 33F25C0580, 33F25D0737, 33F25E1104, 33F25G0438, 33F25G0661, 33F25G0764, 33F25H0211, 33F25H0337, 33F25H0819, 33F25J0965, 33F25L0013, 33F25M0513, 33F26B0641, 33F26B1041, 33F26C0322, 33S25G0438, 33F24M0049; CDC-42703-XP1A/10801902193275, 20801902117087, 10801902162080/33F25K0249, 33F25K0386, 33F25L0091, 33F25L0227, 33F25L0271, 33F25L0301, 33F25M0514, 33F25M0526, 33F25M0546, 33F25M0573, 36F25B0028, 36F25B0066, 36F25D0016, 36F25D0017, 33F24C1215; CDC-42703-XPCN1A/10801902162080, 10801902193275/33F24C1227, 33F24E0237, 33F24E0837, 33F24F0001, 33F24F0161, 33F24F0242,33F24F0243,33F24G0209,33F24G0210, 33F24G0211, 33F24G0212, 33F24H0336, 33F24H0362, 33F24H0404, 33F24J0197, 33F24J0222, 33F24J0259, 33F24K0006, 33F24K0654, 33F24M0023, 33F24M0024, 33F24M0025, 33F24M0058, 33F24M0093, 33F24M0138, 33F24M0151, 33F24M0198, 33F25B0277, 33F25B0376, 33F25B0377, 33F25D0063, 33F25E0797, 33F25E0798, 33F25E1188, 33F25F0067, 33F25F0068, 33F25H0882, 33F25J0680, 33F25J0692, 33F25J0696, 33F25J0701,33F25J0704, 33F25J0709, 33F25J0713, 33F25J0714, 33F25J0716, 33F25J0720, 33F25J0727, 33F25J0731, 33F25K0320, 33F25K0387, 33F25K0388, 33F25K0389, 33F25L0165, 33F25L0183, 33F25L0197, 33F25L0280, 33F25L0294, 33F25M0015, 33F25M0018, 33F25M0024, 33F25M0027, 33F25M0036, 33F25M0574, 33F26A1664, 33F26B0626, 33F26B0627, 33F26C0430, 33F26C0431, 33F26C0432, 36F25B0067, 36F25C0003, 36F25C0004, 36F25D0018, 36F25D0019,36F25D0020, 36F25D0029,36F25E0002, 36F25E0003, 36F25E0004, 36F25E0013, 36F25E0027, 36F25G0001, 36F25G0004, 36F25G0005, 36F25G0008, 36F25G0014, 36F25H0020, 36F25H0021, 36F25H0022, 36F25J0004, 36F25J0006, 33F25F0069; CDC-42802-XPCN1A/10801902162103, 10801902193275/33F24D0791, 33F24F0096, 33F24F0768, 33F24K0367, 33F24L0126, 33F24L0383, 33F24L0893, 33F25A0317, 33F25B0533, 33F25D0563, 33F25D0616, 33F25D0637, 33F25E0702, 33F25E0828, 33F25E0895, 33F25F0220, 33F25H0628, 33F25J0438, 33F26A1567, 33F26C0551, 33F25C0246; CDC-42802-XPN1A/10801902193275, 10801902162097, 10801902170887/33F25D0617, 33F25D0671, 33F25E0896, 33F26A1568, 33F26B0811, 33F26B0945, 33F24D0858; CDC-42854-P1A/10801902170887, 10801902193275, 10801902170887/33F24F0749, 33F24L0128, 33F24L0385, 33F25C0371, 33F25D0672, 33F25E0753, 33F25G0300, 33F25H0548, 33F25J0182, 33F25K0189, 33F25M0081, 33F26A1474, 33F26B0709, 33F26B0806, 33F25H0877; CDC-45703-P1A/10801902171525/33F24D0988, 33F24E0239, 33F24E0252, 33F24E0841, 33F24F0164, 33F24F0225, 33F24G0208, 33F24G0253, 33F24H0079, 33F24H0308, 33F24H0337, 33F24J0225, 33F24J0262, 33F24K0049, 33F24K0690, 33F24L0015, 33F24M0033, 33F24M0034, 33F24M0080, 33F24M0094, 33F24M0140, 33F24M0152, 33F25A0369, 33F25A0387, 33F25B0230, 33F25B0300, 33F25B0345, 33F25C0534, 33F25D0725, 33F25E0419, 33F25E1127, 33F25E1157, 33F25F0026, 33F25F0053, 33F25G0036, 33F25G0055, 33F25G0517, 33F25H0364, 33F25H0784, 33F25J0591, 33F25K0244, 33F25L0053, 33F25L0235, 33F24H0376; CDC-45703-XPB1A/10801902193275, 10801902168372/33F25D0377, 33F25H0553, 33F25J0329, 33F26B0885, 33F24D0499; CDC-45703-XPCN1A/10801902161243, 10801902193275, 10801902161243/33F24E0212, 33F24E0216, 33F24E0217, 33F24E0230, 33F24E0231, 33F24E0243, 33F24E0244, 33F24E0255, 33F24E0256, 33F24E0827, 33F24F0237, 33F24F0240, 33F24F0241, 33F24G0214,33F24G0215, 33F24G0216, 33F24G0256, 33F24G0257, 33F24G0258, 33F24H0083, 33F24H0311, 33F24H0312, 33F24H0313, 33F24H0314, 33F24H0340, 33F24H0366, 33F24H0407, 33F24H0440, 33F24H0462, 33F24K0635, 33F24K0636, 33F24K0637, 33F24K0646, 33F24K0647, 33F24K0653, 33F24M0026, 33F24M0027, 33F24M0028, 33F24M0029, 33F24M0030, 33F24M0031, 33F24M0184, 33F24M0195, 33F24M0196, 33F24M0201, 33F24M0202, 33F25C0589, 33F25C0691, 33F25C0716, 33F25C0717, 33F25E0787, 33F25E0789, 33F25E0799, 33F25E0800, 33F25E1181, 33F25E1182, 33F25E1183, 33F25E1185, 33F25E1186, 33F25E1187, 33F25F0061, 33F25F0063, 33F25F0065, 33F25F0329, 33F25F0330, 33F25F0331, 33F25F0343, 33F25F0344, 33F25F0345, 33F25J0086, 33F25J0087, 33F25J0088, 33F25J0290, 33F25J0293, 33F25J0663, 33F25J0674, 33F25J0675, 33F25J0676, 33F25J0677, 33F25J0683, 33F25J0685, 33F25J0686, 33F25J0694, 33F25J0698, 33F25J0699, 33F25J0703, 33F25J0706, 33F25J0707, 33F25J0719, 33F25K0306, 33F25K0307, 33F25K0391, 33F25K0392, 33F25K0393, 33F25L0001, 33F25L0051, 33F25L0052, 33F25L0065, 33F25L0080, 33F25L0087, 33F25L0088, 33F25L0215, 33F25L0247, 33F25L0282, 33F25L0300, 33F25L0321, 33F25L0326, 33F25M0004, 33F25M0022, 33F25M0023, 33F25M0030, 33F25M0038,33F25M0473, 33F25M0516, 33F25M0535, 33F26A0211, 33F26A1640, 33F26A1641, 33F26A1642, 33F26A1643, 33F26B0612, 33F26B0613, 33F26B0614, 33F26B0615, 33F26B0616, 33F26B0617, 33F26B0618, 33F26B0619, 33F26C0321, 33F26C0543, 33F26C0553, 33F26C0564, 33F26C0568, 33F26C0844, 33F26C0861, 33F26C0877, 33F26C0878, 33F26C0879, 33F26C0880, 33R24M0184, 33X25H0001, 33X25K0005, 36F25C0001, 36F25C0002, 36F25C0009, 36F25C0012, 36F25D0007, 36F25D0012, 36F25D0024, 36F25D0025, 36F25D0026, 36F25D0036, 36F25D0037, 36F25E0005, 36F25E0006, 36F25E0010, 36F25E0011, 36F25E0024, 36F25E0025, 36F25G0006, 36F25G0007, 36F25G0009, 36F25G0010, 36F25G0016, 36F25G0017, 36F25G0018, 36F25H0023, 36F25H0024, 33F25E0795; CDC-45703-XPN1A/10801902193275, 10801902162042/33F25F0333, 33F25F0338, 33F25J0294, 33F25J0673, 33F25J0684, 33F25J0780, 33F25L0249, 33F25M0684,33F25M0775, 33F26A0311, 33F26B0608, 33F26B0609, 33F26B0610, 33F26B0611, 33F26B0685, 33F26B1036, 33F26B1055, 33F26B1057, 33F26B1058, 36F25D0027, 36F25D0033, 36F25D0039,36F25D0040, 36F25E0007, 36F25E0012, 36F25E0014, 36F25E0015, 36F25E0022, 36F25E0023, 36F25G0011, 36F25G0015, 36F25G0026, 36F25G0027, 36F25G0028, 36F25H0003, 36F25H0004, 36F25H0005, 36F25H0012, 36F25H0018, 36F25H0019, 36F25H0025, 36F25H0027, 36F25J0001,36F25J0002, 33F25B0505; CDC-45802-XP1A/10801902193275, 10801902162110/33F25D0568, 33F25E0755, 33F25G0275, 33F25H0434, 33F25J0119, 33F25L0107, 33F25M0347, 33F26A1473, 33F24D0771; CDC-45802-XPCN1A/10801902193275, 10801902162110/33F24K0407, 33F24L0495, 33F25B0490, 33F25D0569, 33F25E0756, 33F25G0380, 33F25J0120, 33F26B0890, 33F25A0290; CDC-46702-XP1A/10801902193275, 10801902168389/33F25E0447, 33F25E0706, 33F25J0332, 33F26A1471, 33F26B0218, 33F25B0506; CDC-47702-XP1A/10801902193275, 10801902168396, 20801902118787/33F25D0573, 33F25F0133, 33F25H0441, 33F25J0185, 33F25K0192, 33F25M0409, 33F26B0710, 33F26B0804, 33F26C0779, 33F24A0137; ASK-45703-PTJH/20801902116400/33F25A0016, 33F25C0585;

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 23 of 35

Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH; PSI KIT: 9 FR X 10 CM/ASK-09903-PHP1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-UPA; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-YNH; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09907-SL; PSI KIT: 8.5 FR X 4-1/8IN (10 CM)/NA-09803-CDC; PSI KIT: 9 FR X 4-1/8IN (10 CM)/NA-09903-CDC; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL4; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-MGH3; MULTI-LUMEN/PSI KIT/AK-11142-SPCS; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/CDC-11242-1A; MULTI-LUMEN/PSI KIT/AK-11142-D; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-11142-MGH4; MULTI-LUMEN/PSI KIT/NA-11242-CDC; MULTI-LUMEN/PSI KIT/AK-21142-SK; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDTG; MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-RH; MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-IMC; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDTG; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMD; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UU3; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-VCU; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-1A; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-X1A; MULTI-LUMEN/PSI KIT/AK-21242-CDC; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH4; MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-GH1; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-SUU; 2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC4; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UKL; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMF; MULTILUMEN/PSI KIT: 9 FR X 4 1/2 IN/ASK-21242-UR1; PSI KIT: 8.5 FR/AK-29803-CDC; PSI KIT: 9 FR/AK-29903-CDC; PSI KIT: 9 FR/AK-29907-CDC; PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-UN1; PSI KIT: 9 FR/ASK-09903-UM; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDT; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDTG; PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-BID1; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDTG; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UMD; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-UR1; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-X1A; PSI KIT: 8.5 FR X 10 CM/ASK-29803-ECL; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-UPM3; PSI KIT: 9 FR X 10 CM/ASK-29903-ECL; PSI KIT: 9FR X 4IN (10 CM) ANTIMICROBIAL/ASK-29903-UPM3; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09907-TG1

Z-2385-2026

Recall number: Z-2385-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 426,041

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): GU-04020/30801902118807, 10801902193275, 30801902118807, 30801902118807/33F24C0753, 33F24E0736, 33F24G0154, 33F24G0648, 33F24H0377, 33F25A0059, 33F25A0072, 33F25A0395, 33F25F0260, 33F25G0736, 33F25H0298, 33F25J0603, 33F26B0084, 33F26B0314, 33F26C0578, 33F24D0036; AK-09803-CDC/20801902121756, 10801902193275, 10801902117417/33F24B0126, 33F24B0127, 33F24C0021, 33F24D0021, 33F24E0072, 33F24G0338, 33F24G0587, 33F24J0506, 33F24K0105, 33F24L0722, 33F25A0468, 33F25C0107, 33F25C0953, 33F25E0054, 33F25E0921, 33F25G0086, 33F25H0023, 33F25J0828, 33F25K0255, 33F25K0364, 33F25L0328, 33F24A0239; AK-09903-CDC/10801902117417, 10801902193275, 20801902121916/33F24A0356, 33F24B0128, 33F24B0129,33F24C0022, 33F24D0022, 33F24E0074, 33F24E0075, 33F24G0340, 33F24G0588, 33F24J0507, 33F24K0107, 33F24L0676, 33F24L0759, 33F25A0470, 33F25C0108, 33F25C0730, 33F25E0056, 33F25E0923, 33F25H0025, 33F25J0471, 33F25K0031, 33F25L0237, 33F25M0920, 33F26A1053, 33F24A0386; ASK-09810-PCMH1/10801902193275/33F25K0051, 33F24J0109; ASK-09903-KH/10801902119350, 10801902193275/33F24D0713, 33F24K0385, 33F24L1060, 33F25D0340, 33F25E0778, 33F25H0567, 33F25M0163, 33F26A1407, 33F25E1184; ASK-09903-PHP1/10801902193275, 10801902115222/33F24J0115, 33F25H0497, 33F26A0410, 33F24F0625; ASK-09903-UPA/10801902193275, 10801902118193/33F24K0387, 33F24L0855, 33F24A0787; ASK-09903-YNH/10801902118193, 10801902193275, 10801902118209/33F24E0527, 33F24H0478, 33F24L0682, 33F25H0135, 33F25J0915, 33F24A0110; ASK-09907-SL/10801902118209, 10801902193275/33F24D0053, 33F24D0967, 33F24G0265, 33F25E0215, 33F25E0454, 33F25G0680, 33F25J0551, 33F25K0328, 33F25L0206, 33F26C0312, 33F25B0188; NA-09803-CDC/10801902119930, 10801902193275, 10801902119947/33F24C0756, 33F24E0739, 33F25A0342, 33F25J0615, 33F26B0028, 33F24A1327; NA-09903-CDC/10801902119947, 10801902193275, 10801902119954/33F24E0740, 33F24H0381, 33F24J0199, 33F24J0361, 33F24L0020, 33F25B0278, 33F25C0551, 33F25E0340, 33F25E0400, 33F25E0468, 33F25F0419, 33F25H0708, 33F26A1655, 33F26B0023, 33F24A0113; ASK-09903-ECL4/10801902193275, 10801902224344/33F26A1582, 33F26B0399, 33F25E0534; ASK-09903-MGH3/10801902193275, 10801902189841, 10801902212006/33F25C0264, 33F25G0338, 33F25J0360, 33F25K0130, 33F26B0126, 33F26C0004, 33F24D0780; AK-11142-SPCS/10801902196412, 10801902193275, 60801902123093/33F24A0382, 33F24A1019, 33F24C0024, 33F24E0078, 33F24E0154, 33F24G0343, 33F24J0510, 33F24K0110, 33F24L0673, 33F25A0472, 33F25C0381, 33F25C0389, 33F25C0952, 33F25E0059, 33F25H0027, 33F25J0831, 33F25K0302, 33F25L0365, 33F26B0514, 33S24J0510, 33F24D0075; CDC-11242-1A/60801902116736, 10801902193275, 40801902111768/33F24D0431, 33F24E0213, 33F24F0140, 33F24F0220, 33F24G0103, 33F24H0392, 33F24H0425, 33F24H0450, 33F24L0011, 33F25B0018, 33F25B0096, 33F25D0705, 33F25E1120, 33F25F0024, 33F25F0414, 33F25G0043, 33F25G0486, 33F25J0016, 33F25J0992, 33F25K0308, 33F25M0481, 33F24C1001; AK-11142-D/20801902121916, 10801902193275, 10801902196412/33F24A1018, 33F24C0023,33F24E0077, 33F24G0342,33F24J0509, 33F24K0109, 33F24L0615, 33F25A0471, 33F25C0842, 33F25E0058, 33F25G0088, 33F25J0472, 33F25K0301, 33F25L0467, 33F26B0593, 33F26B0958, 33F24A0252; ASK-11142-MGH4/10801902193275, 10801902189865, 10801902182545/33F25D0466, 33F25F0113, 33F25L0130, 33F25M0398, 33F26A1539, 33F26B0680, 33F24D0736; NA-11242-CDC/10801902119954, 10801902193275, 10801902119978/33F24A0817, 33F24A1218, 33F24B0399, 33F24C0270, 33F24G0554, 33F24J0663, 33F24L0743, 33F25C0197, 33F25C0870, 33F25E0273, 33F25H0179, 33F25H0761, 33F25L0419, 33F26B0562, 33F24C0271; AK-21142-SK/10801902193275, 30801902122248, 30801902122255/33F24G0356, 33F24G0589, 33F24J0520, 33F24K0122, 33F24L0670, 33F25A0480, 33F25C0720, 33F25E0071, 33F25H0030, 33F25J0837, 33F25L0473, 33F25M0964, 33F26A1097, 33F26B0956, 33R24L0670, 33F24D0023; ASK-21142-LMDTG/10801902193275/33F25K0417, 33F25F0007; ASK-21142-RH/10801902193275/10801902129953/33F24J0108, 33F24L0165, 33F24M0172, 33F25B0422, 33F25E1172, 33F25H0776, 33F25K0424, 33F26C0337, 33F25A0245; ASK-21242-IMC/10801902193275, 10801902118407/33F24G0500, 33F24J0631, 33F24K0255, 33F24L0609, 33F25A0572, 33F25E0223, 33F25H0142, 33F25J0921, 33F26B0543, 33F25C0696; ASK-21242-LMDTG/10801902193275, 10801902220827/33F25G0202, 33F25H0414, 33F25K0382, 33F25M0130, 33F26C0378, 33F24H0123; ASK-21242-UMD/10801902193275/33F24K0476, 33F24L0315, 33F25B0196, 33F25C0279, 33F25D0476, 33F25H0492, 33F25J0378, 33F25M0150, 33F26A1365, 33F25B0551; ASK-21242-UU3/10801902193275/33F24G0503, 33F24L0652, 33F25C0181, 33F25E0226, 33F25H0144, 33F25J0556, 33F24K0077; ASK-21242-VCU/10801902193275, 10801902112962/33F24K0694, 33F25G0171, 33F25H0495, 33F25J0379, 33F26C0494, 33F25C0439; CDC-21242-1A/50801902116821, 10801902193275/33F24D0486, 33F24D0981, 33F24E0227, 33F24F0175, 33F24G0104, 33F24H0296, 33F24H0305, 33F24H0331, 33F24H0357, 33F24H0393, 33F24H0427, 33F24M0019, 33F24M0055, 33F25A0131, 33F25A0367, 33F25B0019, 33F25C0511, 33F25D0706, 33F25E0417, 33F25E1122, 33F25F0416, 33F25G0066, 33F25G0476, 33F25G0711, 33F25H0852, 33F25J0964, 33F25K0352, 33F25L0229, 33F26A1614, 33F26A1624, 33F26A1649, 33F24H0332; CDC-21242-X1A/10801902193275, 30801902116834, 10801902196511/33F25J0291, 33F25J0672, 33F25J0678, 33F25J0690, 33F25J0700, 33F25J0708, 33F25J0724, 33F25L0067, 33F26A1616, 33F26A1625, 33F26B0642, 36F25B0014, 36F25E0020, 36F25G0029, 36F25H0016, 36F25J0005, 33F24C0518; AK-21242-CDC/30801902122255, 10801902193275, 30801902122262/33F24E0082, 33F24E0083, 33F24J0521, 33F24K0123, 33F24L0618, 33F25A0481, 33F25C0946, 33F25E0072, 33F25H0031, 33F25K0037, 33F25K0414, 33F25L0372, 33F26B0520, 33F26C0626, 33F24E0352; ASK-21142-FH4/10801902193275/33F24L0683; ASK-21142-GH1/10801902193275/33F25C0180, 33F25E1023, 33F25H0141, 33F25H0752, 33F25J0920, 33F25L0455, 33F25B0276; ASK-21142-SUU/10801902193275/33F25J0096, 33F25C0275; ASK-21142-UPMC4/10801902193275/33F25A0247; ASK-21242-UKL/10801902114065, 10801902193275, 10801902136487/33F24F0710, 33F24K0467, 33F24L0314, 33F25B0195, 33F25C0278, 33F25D0475, 33F25G0412, 33F25J0149, 33F25M0202, 33F26A1551, 33F26C0010, 33F26C0759, 33F24F0849; ASK-21242-UMF/10801902193275, 10801902129502/33F25D0477, 33F25H0487, 33F25J0150, 33F25K0096, 33F24D0715; ASK-21242-UR1/10801902193275, 10801902119435, 10801902118902/33F25E0225, 33F25J0555, 33F25L0427, 33F25M0928, 33F26C0261, 33F24E0542; AK-29803-CDC/10801902193275, 20801902117506/33F24G0378, 33F24J0283, 33F24J0533, 33F24K0141, 33F24L0620, 33F25A0488, 33F25C0901, 33F25E0090, 33F25G0095, 33F25H0039, 33F25J0487, 33F25L0389, 33F25M0893, 33F26A1021, 33F26B0537, 33F26C0262, 33F24G0379; AK-29903-CDC/10801902193275, 10801902117516, 10801902117523/33F24J0345, 33F24J0534, 33F24K0142,33F24L0672, 33F25A0489, 33F25C0904, 33F25E0091, 33F25G0096, 33F25H0040, 33F25J0488, 33F25L0382, 33F25M0889, 33F26B0533, 33F24D0091; AK-29907-CDC/10801902117523, 10801902193275/33F24E0377, 33F24J0535, 33F24L0606, 33F25C0122, 33F25C0854, 33F25E0092, 33F25H0041, 33F25J0848, 33F26B0503, 33F25A0146; ASK-09804-UN1/10801902193275, 10801902145847/33F25H0485, 33F26A0248, 33F24B0018; ASK-09903-UM/10801902193275, 10801902118186/33F25B0432, 33F25F0361, 33F25L0136, 33F24D0545; ASK-29803-LMDT/10801902193275, 10801902220810/33F25H0367, 33F25J0153, 33F25K0258, 33F25K0418, 33F26A1354, 33F26C0357, 33F25G0464; ASK-29803-LMDTG/10801902193275, 10801902220858/33F25H0413, 33F25H0585, 33F25K0207, 33F25K0419, 33F25M0198, 33F25M0440, 33F26C0170, 33F24G0607; ASK-29903-BID1/10801902193275/33F25K0066, 33F26A0251, 33F24H0139; ASK-29903-LMDTG/10801902193275, 10801902220735/33F25L0025, 33F25M0338, 33F26C0021, 33F24H0124; ASK-29903-UMD/10801902193275/33F25C0583, 33F26A0409, 33F24K0402; ASK-29903-UR1/10801902193275/33F25J0796, 33F24J0107; CDC-29803-X1A/10801902193275, 30801902117022, 10801902193114/33F25F0334, 33F25H0878, 33F25J0292, 33F25K0016, 33F25K0315, 33F25M0088, 33F26A1415, 33F26B0473, 36F25E0019, 36F25G0020, 36F25H0013, 33F24E0214; ASK-29803-ECL/10801902193275, 10801902200478/33F26A1576, 33F24D0625; ASK-29803-UPM3/10801902193275/33F25B0236; ASK-29903-ECL/10801902193275/33F26A1580, 33F25D0235; ASK-29903-UPM3/10801902193275/33F25J0558; ASK-09907-TG1/10801902118216/33F24D1025

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 24 of 35

Description/REF: PARACENTESIS KIT/ASK-00376-JHH

Z-2386-2026

Recall number: Z-2386-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 180

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): ASK-00376-JHH/10801902193275/33F25G0629, 33F24K0592

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 25 of 35

Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC

Z-2387-2026

Recall number: Z-2387-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 90

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): CDC-32052-MPKC/10801902193275/33F24L0236

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 26 of 35

Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK-12123-UOC1, AHDC KIT: 3-L 12 FR X 16 CM/ASK-12123-UPM, AHDC KIT: 3L 12 FR X 20 CM/ASK-15123-UOC1, AHDC KIT: 3-L 12 FR X 20 CM/ASK-15123-UPM, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-P1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XP1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPCN1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPN1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-P1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPCN1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPN1A, AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPCN1A, HEMODIALYSIS KIT 2L: 12 FR X 20CM AGB/AK-25122-CDC, HEMODIALYSIS KIT: 2-LUMEN 14 FR X 20 CM/AK-25142-F, HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM1, HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM2, AHDC KIT: 2L 14 FR X 15 CM/ASK-22142-UOC1, AHDC AGB KIT: 2-L 14 FR X 15 CM/ASK-22142-UPM, HEMODIALYSIS KIT: 2L 14 FR X 20 CM/ASK-25142-UNC1, AHDC KIT: 2L 14 FR X 20 CM/ASK-25142-UOC1, AHDC AGB KIT: 2L 14 FR X 20 CM/ASK-25142-UPM, HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/ASK-26142-UNC1, HEMODIALYSIS KIT: 2LUMEN 12 FR X 16 CM/AU-22122-F, HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A-U, AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A-U, HEMODIALYSIS KIT 2L: 14 FR X 15 CM AGB/CDC-22142-1A, HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB/CDC-22142-XC1A, AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A-C, AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A-C, AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XCN1A-U, AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XN1A-U, HEMODIALYSIS KIT: 2L 12 FR X 13 CM AGB/CDC-23122-XU1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-X1A, AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A-U, AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XN1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-XU1A, HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB/CDC-25142-1A, HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB/CDC-25142-XC1A, AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A-C, AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A-C, HEMODIALYSIS KIT: 2L 12 FR X 25 CM AGB/CDC-26122-1A, AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XCN1A, AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XN1A, HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/CDC-26142-1A, HEMODIALYSIS KIT: 2L 14 FR X 25 CM AGB/CDC-26142-X1A, AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XCN1A, AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XN1A, HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-25122-F, AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A, LBCVC AGB KIT: 3-L 12 FR X 16 CM/CDC-22123-XCN1A, LBCVC AGB KIT: 3-L 12 FR X 20 CM/CDC-25123-XCN1A, LBCVC AGB KIT:3-L 12 FR X 20 CM/CDC-25123-XN1A

Z-2388-2026

Recall number: Z-2388-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 62,719

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): AK-15122-F/10801902197136, 10801902193275, 10801902168525/33F24E0348, 33F24J0280, 33F24K0119, 33F24L0601, 33F25A0477, 33F25C0908, 33F24A0850; ASK-12123-UOC1/10801902193275/33F25B0430, 33F25D0119; ASK-12123-UPM/10801902193275, 10801902222463/33F25E0535, 33F25G0188, 33F25G0189, 33F26C0333, 33F25D0262; ASK-15123-UOC1/10801902193275/33F25C0378, 33F25D0121; ASK-15123-UPM/10801902193275, 10801902159950/33F25E0718, 33F25H0447, 33F26A1389, 33F24E0649; CDC-12123-P1A/40801902111768, 10801902193275/33F24D0632, 33F24F0758, 33F24L0465, 33F25A0281, 33F25E0794; CDC-12123-XP1A/10801902193275, 30801902111785, 10801902213416/33F25J0723, 33F26A1382, 33F26B0433, 36F25A0007, 36F25B0009, 36F25E0018, 33F24D0299; CDC-12123-XPCN1A/10801902213416, 10801902193275/33F24D0950, 33F24K0417, 33F24L0466, 33F25A0216, 33F25B0667, 33F25D0436, 33F25D0666, 33F25E0693, 33F25G0239, 33F25J0247, 33F26A1556, 33F26B0801, 33F26C0767, 33F25B0668; CDC-12123-XPN1A/10801902193275, 10801902213409/33F25D0554, 33F25G0240, 33F25J0312, 33F26B0214,33F26C0199, 33F25A0181; CDC-15123-P1A/10801902193275/33F25D0437, 33F25H0547,33F25B0613; CDC-15123-XPCN1A/10801902213430, 10801902193275/33F24F0107, 33F24F0998, 33F24K0403, 33F24L0834, 33F25A0283, 33F25B0527, 33F25E0650, 33F25E0745, 33F25F0085, 33F25H0596, 33F25J0314, 33F26A1464, 33F26B0883, 33F25B0669; CDC-15123-XPN1A/0801902193275, 10801902213423, 10801902116793/33F25D0439, 33F25G0238, 33F25H0597, 33F25J0315, 33F26A1468, 33F26B0826, 33F24C0461; CDC-16123-XPCN1A/10801902193275/33F25B0671, 33F25D0440, 33F25E0651, 33F25G0236, 33F25H0529, 33F25J0316, 33F25G0237, AK-25122-CDC/10801902193275/33F24G0370, 33F24K0135, 33F25C0120, 33F25C0969, 33F25E0942, 33F24G0371; AK-25142-F/10801902193275, 70801902123205, 10801902167795/33F25C0863, 33F25E0087, 33F25H0038, 33F25J0846, 33F26B0531, 33F24D0089; ASK-22122-MM1/10801902193275/33F25E0546; ASK-22122-MM2/10801902193275, 10801902221923, 10801902144956/33F25G0172, 33F25L0031, 33F25M0310, 33F26A1652, 33F26B0151, 33F26B0450, 33F24F0854; ASK-22142-UOC1/10801902193275/33F25C0545, 33F25D0122; ASK-22142-UPM/10801902193275, 10801902222487, 10801902202281/33F25D0594, 33F25F0116, 33F25G0187, 33F26A1390, 33F26B0205, 33F24D0396; ASK-25142-UNC1/10801902193275/33F25C0655, 33F24K0561; ASK-25142-UOC1/10801902193275/33F25B0362, 33F25D0123; ASK-25142-UPM/10801902193275/33F25E0595, 33F25H0446, 33F25J0381, 33F26A1446, 33F25J0092; ASK-26142-UNC1/10801902193275/33F25B0427, 33F25K0058; AU-22122-F/10801902193275/33F24K0269, 33F25A0584, 33F25C0862, 33F25E0245, 33F25J0567; CDC-22122-1A/20801902123484, 10801902193275/, CDC-22122-XCN1A-U/33F24F0996, 33F24L0374, 33F25C0461; CDC-22122-XN1A/10801902193275/33F25C0239, 33F25E0875, 33F25J0419; CDC-22122-XN1A-U/10801902193275, 10801902213621/33F25A0309, 33F25E0876, 33F26B0217; CDC-22142-1A/50801902123515, 10801902193275/33F24D0928, 33F24F0103, 33F24F0896, 33F24L0111, 33F24L0955, 33F25B0500, 33F25D0447, 33F25E0654, 33F25G0278, 33F25H0577, 33F25J0319; CDC-22142-XC1A/10801902193275/33F25A0284, 33F25J0180; CDC-22142-XCN1A/10801902193275, 10801902213539/33F25A0285, 33F25B0529, 33F25D0449, 33F25E0655, 33F25E0818, 33F25F0214, 33F25G0233, 33F26A1477, 33F26B0898, 33R25J0455; CDC-22142-XCN1A-C/10801902193275/33F24L0473, 33F25B0615, 33F25F0213; CDC-22142-XN1A/10801902193275, 10801902213522/33F25C0240, 33F25E0578, 33F25F0215, 33F25H0528, 33F25J0321, 33F26A1383, 33F26B0215, 33F26C0016; CDC-22142-XN1A-C/10801902193275/33F25B0485, 33F25E0879; CDC-23122-XCN1A-U/10801902193275/33F24L0279, 33F25D0492; CDC-23122-XN1A-U/10801902193275/33F25E0579; CDC-23122-XU1A/10801902193275/33F25D0493, 33F25H0432, 33F25J0248; CDC-25122-1A/10801902193275/33F25B0619, 33F25E0881; CDC-25122-X1A/10801902193275/33F25E0882, 33F25J0422; CDC-25122-XCN1A/10801902213492, 10801902193275/33F24F0929, 33F25C0242, 33F25D0498, 33F25E0883, 33F25G0234, 33F26B0439, 33F26C0214; CDC-25122-XCN1A-U/10801902193275/33F24L1041, 33F25B0620, 33F25F0121, 33F25G0226; CDC-25122-XN1A/10801902193275, 10801902213485/33F25C0243, 33F25E0884, 33F25K0183, 33R25E0884; CDC-25122-XU1A/10801902193275/33F25B0621, 33F25E0886, 33F25H0568; CDC-25142-1A/50801902123584, 10801902193275/33F24F0837, 33F24K0457, 33F24L0113, 33F24L1031, 33F25B0622, 33F25D0503, 33F25E0889, 33F25F0106, 33F25J0127; CDC-25142-XC1A/10801902193275/33F25B0467; CDC-25142-XCN1A/10801902193275, 10801902213553/33F25A0312, 33F25E0657, 33F25E0821, 33F25G0231, 33F25H0527, 33F25J0428, 33F26B0452, 33F26C0133; CDC-25142-XCN1A-C/10801902193275/33F24L0377, 33F25D0238; CDC-25142-XN1A/10801902193275, 10801902213546/33F25B0624, 33F25D0504, 33F25E0823, 33F25G0232, 33F26B0437; CDC-25142-XN1A-C/10801902193275/33F24L0485, 33F25B0676; CDC-26122-1A/60801902123611, 10801902193275/33F24F0084, 33F24K0475, 33F25G0389; CDC-26122-XCN1A/10801902213515, 10801902193275/33F24F1028, 33F24L0117, 33F25D0308, 33F25D0557, 33F25F0219; CDC-26122-XN1A/10801902193275/33F25E0451; CDC-26142-1A/10801902193275/33F24L0488, 33F24L1025, 33F25C0368, 33F25E0891, 33F25H0406, 33F25J0116; CDC-26142-X1A/10801902193275/33F25D0558, 33F25E0892; CDC-26142-XCN1A/10801902193275, 10801902213577/33F24L0941, 33F25B0530, 33F25D0507, 33F25E0699, 33F25H0525, 33F26B0396, 33F26B0895, 33F26C0780; CDC-26142-XN1A/10801902193275, 10801902213560/33F24L0927, 33F25E0580, 33F25H0526, 33F26B0393; AK-25122-F/ CDC-22122-XCN1A/10801902193275/33F24G0371, 33F24L0742, 33F25C0822, 33F25E0084, 33F25J0483, 33F25L0400; CDC-22123-XCN1A/10801902213591, 10801902193275/33F24D0842,33F24F1018, 33F24L0110, 33F25C0205, 33F25D0613, 33F25E0878, 33F26B0455; CDC-25123-XCN1A/10801902213614, 10801902193275/33F24D0818, 33F24L0483, 33F25C0244, 33F25D0502, 33F25E0888, 33F25G0228, 33F25J0425, 33F26B0395, 33F26B0894; CDC-25123-XN1A/10801902193275/33F25C0332, 33F25G0229

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 27 of 35

Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090-SB; SPINAL ANESTHESIA KIT: 24 GA X 9 CM/ASK-24090-SA; SPINAL ANESTHESIA KIT: 25 GA X 9 CM/ASK-24090-SPH; SPINAL ANESTHESIA KIT/ASK-25090-BIDMC; SPINAL ANESTHESIA KIT/ASK-25090-UF

Z-2389-2026

Recall number: Z-2389-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 79,614

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): ASA-24090-SB/10801902193275, 10801902201994/33F24G0383, 33F24K0145, 33F24L0550, 33F25A0491, 33F25C0838, 33F25E0094, 33F25H0044, 33F25J0490, 33F25L0444, 33S25E0094; ASA-24103-SB/10801902202007, 10801902193275/33F24E0380, 33F24E0381, 33F24G0274, 33F24K0146, 33F24L0696, 33F25A0492, 33F25C0123, 33F25C0774, 33F25E0095, 33F25G0097, 33F25H0045, 33F25J0491, 33F25L0329, 33F26B0494; ASA-25090-SB/10801902202014, 10801902193275/33F24E0089, 33F24E0090, 33F24G0384, 33F24K0147, 33F24L0545, 33F24L0755, 33F25A0493, 33F25A0621, 33F25B0374, 33F25C0844, 33F25E0097, 33F25G0098, 33F25H0046, 33F25J0850, 33F25K0257; ASK-24090-SA/10801902202281, 10801902193275/33F24D0396, 33F24E0544, 33F24L0589, 33F25C0182, 33F25C0965, 33F25E0228, 33F25H0146, 33F25J0922, 33F26B0573; ASK-24090-SPH/10801902202274, 10801902193275/33F24D0397, 33F24G0505, 33F24K0260, 33F24L0654, 33F25A0575, 33F25C0943, 33F25E1026, 33F25H0753, 33F25K0410, 33F26B0501; ASK-25090-BIDMC/10801902210217/33F24E0546, 33F24E0547, 33F24L0636, 33F25C0183, 33F25C0831, 33F25E0230, 33F25J0923, 33F25L0357; ASK-25090-UF/10801902206692, 10801902193275/33F24E0548, 33F24L0602, 33F25C0806, 33F25E0231, 33F25G0138, 33F25J0557, 33F25M0957;

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 28 of 35

Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C; SAC KIT: 18 GA X 16CM W BIO/SAC-01618-B

Z-2390-2026

Recall number: Z-2390-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 0

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): SAC-01218-B/10801902225303/33F26C0515; SAC-01218-C/10801902225273/33F26C0517; SAC-01618-B/10801902225310/33F26C0518

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 29 of 35

Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM5; CATH SL 20 GA X 5 CM HYDROPHILIC/ASK-00520-JH; CATH S-L 20 GA X 5 CM HYDROPHILIC/ASK-00520-UHC; ARTERIAL LINE KIT: 20 GA x 5IN/ASK-00820-CL; RA CATH KIT: 20 GA X 8 CM X 12 CM/ASK-00820-WC; ARTERIAL CATHETERIZATION KIT/ASK-01218-HM; SAC KIT: 20 GA X 12CM/ASK-01220-HMH; ARTERIAL CATH KIT: 20GA X 12CM/ASK-01220-NWM; ARTERIAL CATH KIT: 20 GA X 12 CM/ASK-01220-UH; ARTERIAL CATH: 18 GA X 6 1/2IN/ASK-01618-AU; RA CATH KIT: 18 GA X 6 IN/ASK-01618-CL; ARTERIAL CATH KIT: 18 GA X 6 1/2 IN/ASK-01618-JH; ARTERIAL CATHETERIZATION KIT/ASK-01618-PH; ARTERIAL CATH KIT: 18 GA X 6 1/2IN/ASK-01618-RU; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HF; ARTERIAL CATH KIT: 18 GA X 6 IN (16 CM)/ASK-04018-NS; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-ST; RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04120-BGH; ART/VESS CATH KIT:20GAX4.45CM/20GAX12CM/ASK-04500-SM; ARTERIAL LINE KIT/ASK-04500-UCH; ARTERIAL LINE KIT/ASK-04510-EUH2; ARTERIAL LINE KIT: 20GA X 5IN (12CM)/ASK-04510-MS4; ARTERIAL LINE KIT/ASK-04510-UPM; ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-1A; ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-X1A; ARTERIAL CATH KIT: 22GA X 5CM/SAC-00522-1A ARTERIAL CATH KIT: 22 GA X 5CM/SAC-00522-X1A; ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-1A; ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-X1A; SAC KIT: 18 GA X 12CM/SAC-01218-1A; SAC KIT: 18 GA X 12CM/SAC-01218-X1A; SAC KIT: 20 GA X 12CM/SAC-01220-1A; SAC KIT: 20 GA X 12CM/SAC-01220-X1A; SAC KIT: 18 GA X 16CM/SAC-01618-1A; SAC KIT: 18 GA X 16CM/SAC-01618-X1A; ACCESS TRAY/UM-04018; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-ABM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-BGH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LOL; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MHS; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-MIB3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC1; RA CATH SET: 20 GA X 1 3/4 IN/ASK-04020-URMC; RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04220-FMH1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-1A; RA CATH KIT: 20 GA X 4.45 CM W BIO/NA-04020-B; RA CATH KIT: 20 GA X 4.45 CM W CHG/NA-04020-C; VESSEL CATH KIT: 20 GA X 5IN (12 CM)/ASK-04550-NYP; CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04300-PHP1; CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04301-TJ; ARTERIAL ACCESS KIT/ASK-04001-VAMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-WBH

Z-2391-2026

Recall number: Z-2391-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 491,489

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): AK-04020-SPC/10801902121551, 10801902193275/33F23M0171, 33F24C0729, 33F24E0699, 33F24G0596, 33F24H0057, 33F24J0350, 33F24J0458, 33F24K0615, 33F24M0126, 33F25A0338, 33F25B0039, 33F25B0131, 33F25D0192, 33F25D0281, 33F25E1109, 33F25F0496, 33F25J0764, 33F26B0054; ASK-04020-MW/10801902142983, 10801902193275/33F23M0188, 33F24B0447, 33F24C0744, 33F24E0725, 33F24G0231, 33F24G0669, 33F24H0344, 33F24L0005, 33F24L0024, 33F25A0062, 33F25B0064, 33F25D0290, 33F25D0729, 33F25E0428, 33F25H0328, 33F26B0089, 33F26B0263; ASK-04510-MM5/10801902193275/33F24K0360, 33F25A0237, 33F25B0546; ASK-00520-JH/10801902138788, 10801902193275/33F24D0201, 33F24F0686, 33F24J0128, 33F24K0373, 33F25A0204, 33F25B0541, 33F25D0324, 33F25D0645, 33F25H0429, 33F25H0507, 33F25J0195, 33F26A1380, 33F26B0159, 33F26C0192; ASK-00520-UHC/10801902139839, 10801902193275/33F23L0771, 33F24A0775, 33F24B0219, 33F24C0125, 33F24D0093, 33F24E0383, 33F24G0386, 33F24J0284, 33F24K0149, 33F24L0712, 33F25A0495, 33F25C0125, 33F25C0826, 33F25E0099, 33F25H0047, 33F25J0851, 33F25L0392, 33F26B0540; ASK-00820-CL/10801902193275, 10801902193916/33F24G0275, 33F24J0285, 33F24K0152, 33F24L0590, 33F25A0497, 33F25C0797, 33F25E0102, 33F25H0050, 33F25J0853, 33F25L0385, 33F26B0536; ASK-00820-WC/10801902193275/33F24G0150, 33F24G0227, 33F24G0691, 33F24H0253, 33F24K0624, 33F25B0091, 33F25B0334, 33F25J0574, 33F26B0113; ASK-01218-HM/10801902193275/33F24G0276, 33F24K0551, 33F24L0215, 33F25A0296, 33F25B0543, 33F25E0450, 33F25F0364, 33F25G0163, 33F25G0208, 33F25H0499, 33F25J0100, 33F25J0139; ASK-01220-HMH/10801902193275/33F25B0245, 33F25B0544, 33F25C0698, 33F25D0388; ASK-01220-NWM/10801902193275/33F24H0181, 33F24J0154, 33F24K0497, 33F25F0157, 33F25H0658; ASK-01220-UH/10801902193275/33F24G0391, 33F24J0286, 33F24J0541, 33F24K0154, 33F24L0663, 33F25C0126, 33F25E0104, 33F25E0955, 33F25H0052, 33F25J0494, 33F25J0855, 33F25L0459, 33F25M0952; ASK-01618-AU/10801902205909, 10801902193275/33F24F0213, 33F24K0673, 33F25C0653, 33F25E1171, 33F25L0062, 33F26A0233; ASK-01618-CL/10801902195934, 10801902193275/33F24E0648, 33F24K0355, 33F25A0224,33F25B0493, 33F25D0327, 33F25E0588, 33F25F0158, 33F25J0140, 33F25M0112, 33F26C0366; ASK-01618-JH/10801902138801, 10801902193275/33F24D0584, 33F24K0490, 33F24L0844, 33F25B0494, 33F25D0530, 33F25H0834, 33F25K0264, 33F25K0357, 33S25D0530; ASK-01618-PH/10801902193275/33F24K0749, 33F24L0837, 33F25C0251, 33F25E0019, 33F25G0220; ASK-01618-RU/10801902202304, 10801902193275/33F24B0869, 33F24D1027, 33F25A0102, 33F25C0713, 33F25J0792, 33F25M0618; ASK-04018-HF/10801902193275/33F24H0156, 33F24L0397, 33F25D0391, 33F25G0401, 33F25K0069, 33F25M0142; ASK-04018-NS/10801902193275/33F25E1176, 33F25G0103; ASK-04018-ST/10801902117639, 10801902193275/33F24A0112, 33F24A0826, 33F24B0237, 33F24C0140, 33F24E0402, 33F24E0403, 33F24G0281, 33F24K0163, 33F25A0504, 33F25C0780, 33F25E0115, 33F25G0104, 33F25J0498, 33F25M0917, 33F26B1011; ASK-04120-BGH/10801902117936, 10801902193275/33F24D0518, 33F24G0262, 33F24J0474, 33F25A0150, 33F25C0740, 33F25E1207, 33F25H0096, 33F25K0331; ASK-04500-SM/30801902118012, 10801902193275/33F24A0117, 33F24A1163, 33F24D0059, 33F24D0968, 33F24E0782, 33F24G0263, 33F24J0302, 33F25C0500, 33F25E0162, 33F25H0738, 33F25L0209, 33F25M0617, 33F26B0020, 33F26B0746; ASK-04500-UCH/10801902139464, 10801902193275/33F24E0454, 33F24G0446, 33F24J0588, 33F24K0207, 33F24L0715, 33F25C0155, 33F25C0924, 33F25E0163, 33F25H0739, 33F25L0332, 33F26B0655; ASK-04510-EUH2/10801902193275, 10801902213386/33F24J0303, 33F24L0728, 33F25C0156, 33F25C0803, 33F25E0164, 33F25H0103, 33F25J0522, 33F25L0343, 33F25M0850, 33F26B0660; ASK-04510-MS4/10801902193275, 10801902139709/33F24K0212, 33F24L0764, 33F25C0860, 33F25E0169, 33F25E0994, 33F25J0526, 33F25L0423, 33F26B0654; ASK-04510-UPM/10801902118087, 10801902193275/33F24B0144, 33F24E0101, 33F24E0102, 33F24G0456, 33F24J0595, 33F24K0216, 33F24L0675, 33F25A0544, 33F25C0947, 33F25E0174, 33F25H0107, 33F25J0529, 33F25J0738, 33F25L0022, 33F26B0647, 33F26B0665, 33F26C0617; SAC-00520-1A/10801902140644, 10801902193275/33F24C0780, 33F24E0772, 33F24G0025, 33F24G0675, 33F24H0061, 33F24J0190, 33F24J0207, 33F24J0415, 33F24M0010, 33F25A0097, 33F25B0052, 33F25B0126, 33F25B0410, 33F25C0540, 33F25D0185, 33F25E0408, 33F25E0472, 33F25G0530, 33F25H0832, 33F25J0045, 33F25J1013, 33F25M0704, 33F26B0259; SAC-00520-X1A/10801902193275, 10801902140583/33F24J0208, 33F25A0098, 33F25B0023, 33F25B0127, 33F25B0287, 33F25D0086, 33F25E1180, 33F25F0288, 33F25F0425, 33F25H0347, 33F25H0866, 33F25L0177, 33F26B0058, 33F26B0279; SAC-00522-1A/10801902140606, 10801902193275/33F23L0976, 33F24B0461, 33F24C0783, 33F24E0775, 33F24G0243, 33F24J0242, 33F24J0416, 33F24M0122, 33F25A0389, 33F25B0076, 33F25E0382, 33F25H0348, 33F26B0257; SAC-00522-X1A/10801902193275/33F24L0536, 33F26B0059; SAC-00820-1A/10801902140637, 10801902193275/33F24B0463, 33F24C0785, 33F24E0777, 33F24F0081, 33F24G0136, 33F24H0059, 33F24H0352, 33F24H0388, 33F24L0057, 33F24M0011, 33F24M0123, 33F25A0134, 33F25B0109, 33F25B0282, 33F25B0646, 33F25C0543, 33F25C0568, 33F25D0094, 33F25D0186, 33F25D0302, 33F25E0364, 33F25F0045, 33F25J0581, 33F25J0980, 33F25K0298, 33F25K0338; SAC-00820-X1A/10801902193275, 10801902140620/33F25C0491, 33F25C0544, 33F25D0073, 33F25E0409, 33F25F0055, 33F25H0801, 33F25J0660, 33F25K0337, 33F25L0193, 33F25M0697, 33F26B0068, 33F26B0702; SAC-01218-1A/10801902199734, 10801902193275/33F24A1699, 33F24D0559, 33F24E0668, 33F24F1031, 33F25A0203, 33F25C0455, 33F25D0580, 33F25J0189, 33F26C0035; SAC-01218-X1A/10801902193275, 10801902199741/33F24J0138, 33F24L0960, 33F25A0294, 33F25B0537, 33F25C0479, 33F25E0768, 33F25H0618, 33F25J0451, 33F26A1374, 33F26B0775; SAC-01220-1A/10801902199758, 10801902193275/33F24C0971, 33F24D0361, 33F24F0986, 33F24L0509, 33F25A0221, 33F25B0481, 33F25C0374, 33F25D0635, 33F25E0711, 33F25G0297, 33F25J0133, 33F26A1362, 33F26B0458, 33F26C0680; SAC-01220-X1A/10801902193275, 10801902140989/33F24J0163, 33F24L0148, 33F25A0194, 33F25B0470, 33F25B0680, 33F25D0636, 33F25E0841, 33F25G0411, 33F25J0259, 33F26A1449, 33F26B0202, 33F26C0168; SAC-01618-1A/10801902199765, 10801902193275/33F24A0983, 33F24A1565, 33F24C0373, 33F24C1010, 33F24D0323, 33F24D0875, 33F24F0992, 33F24K0364, 33F24L0394, 33F24L1126, 33F25A0295, 33F25B0510, 33F25C0250, 33F25D0258, 33F25D0385, 33F25D0581, 33F25E0712, 33F25E0903, 33F25F0231, 33F25G0402, 33F25J0123, 33F25J0340, 33F26A1356, 33F26A1509, 33F26B0941, 33F26D0311; SAC-01618-X1A/10801902193275, 10801902145489/33F24J0144, 33F24L0395, 33F25A0222, 33F25B0511, 33F25D0259, 33F25D0321, 33F25D0458, 33F25E0770, 33F25F0232, 33F25G0264, 33F25G0383, 33F25J0134, 33F25J0452, 33F26A1435, 33F26B0842, 33F26B0939, 33F26B0940; UM-04018/10801902192063, 10801902193275/33F24A0359, 33F24A0360, 33F24A0361, 33F24A1061, 33F24A1062, 33F24B0162, 33F24B0163, 33F24B0164, 33F24C0053, 33F24D0042, 33F24D0043, 33F24H0463, 33F24H0464, 33F24J0466, 33F24K0306, 33F24K0311, 33F24K0543, 33F24L0723, 33F24L0761, 33F25A0608, 33F25C0209, 33F25E0284, 33F25E0297, 33F25E0742, 33F25E1061, 33F25E1069; ASK-04020-ABM/10801902193275, 10801902218947/33F24J0341, 33F24J0551, 33F24L0700, 33F25C0923, 33F25E0117, 33F25J0500, 33F25L0468, 33F26B0995; ASK-04020-BGH/10801902117660, 10801902193275/33F24A0814, 33F24C0142, 33F24D0109, 33F24E0406, 33F24G0404, 33F24J0554, 33F24L0634, 33F25A0507, 33F25C0809, 33F25E0120, 33F25H0064, 33F25J0867, 33F25L0386, 33F25M0890; ASK-04020-LOL/10801902193275, 10801902144765/33F24G0417, 33F24J0566, 33F24K0180, 33F24L0780, 33F25C0993, 33F25H0077, 33F25H0733, 33F25J0670, 33F25L0425, 33F26C0318, 33S24B0254, 33S24C0155; ASK-04020-MHS/20801902117711, 10801902193275/33F24A0380, 33F24A1033, 33F24B0255, 33F24C0157, 33F24D0121, 33F24E0420, 33F24H0476, 33F24J0568, 33F24K0181, 33F25C0990, 33F25E0137, 33F25G0111, 33F25H0078, 33F25J0505, 33F25L0377, 33F26B0526, 33S24A1033, 33S24B0255, 33S24C0157, 33S24D0121, 33X24K0003; ASK-04020-MIB3/10801902193275/33F24L0687, 33F25C0859, 33F25E0981, 33F25J0878, 33F26A0967; ASK-04020-PMC1/10801902193275/33F25C0489; ASK-04020-URMC/10801902117868, 10801902193275/33F24A0142, 33F24A0870, 33F24B0274, 33F24C0173, 33F24D0136, 33F24E0442, 33F24G0436, 33F24L0644, 33F25A0530, 33F25E0151, 33F25H0091, 33F25J0888; ASK-04220-FMH1/10801902193275/33F24K0203, 33F25A0535, 33F25E0158, 33F25J0890; NA-04020-1A/10801902119916, 10801902193275/33F24A1057, 33F24B0153, 33F24C0045, 33F24D0039, 33F24G0549, 33F24J0333, 33F24K0293, 33F24L0678, 33F25A0597, 33F25C0900, 33F25E0267, 33F25E1047, 33F25G0150, 33F25H0174, 33F25H0666, 33F25J0664, 33F25K0403, 33F25L0023, 33F25L0436, 33F25M0936, 33F26B0577; NA-04020-B/10801902193275, 10801902221312/33F24L0072, 33F25A0598, 33F25C0763, 33F25E0268, 33F25E1048, 33F25H0175, 33F25H0667, 33F25J0632, 33F26B0530; NA-04020-C/10801902193275, 10801902221329/33F24L0073, 33F25A0599, 33F25C0926, 33F25E0269, 33F25E1049, 33F25G0151, 33F25H0176, 33F25H0668, 33F26B0529; ASK-04550-NYP/10801902130836, 10801902193275/33F24F0685, 33F24H0144, 33F24K0424, 33F25A0166, 33F25B0170, 33F25B0495, 33F25D0337, 33F25G0355, 33F25H0431, 33F25H0639, 33F26A1367, 33F26A1542, 33F26C0585; ASK-04300-PHP1/10801902143805, 10801902193275/33F24F0619, 33F24H0147, 33F24K0072, 33F24M0047, 33F25C0649, 33F25K0314, 33F25L0029, 33F25M0066; ASK-04301-TJ/20801902114987, 10801902193275/33F24D0733, 33F24F0798, 33F25A0235, 33F25B0516; ASK-04001-VAMC1/10801902158854, 10801902193275/33F24E0400, 33F24G0400, 33F24K0161, 33F25A0502, 33F25E0114, 33F25J0863, 33F25L0387, 33F26B1016; ASK-04020-WBH/10801902117899/33F24C0174, 33F24D0138, 33F24E0445, 33F24G0438, 33F24J0582, 33F24L0793;

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 30 of 35

Description/REF: ACCESS TRAY/ASK-04001-MC3

Z-2392-2026

Recall number: Z-2392-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 8,265

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): ASK-04001-MC3/

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 31 of 35

Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU5; PSI KIT: 8.5 FR/ASK-09807-UC; PSI KIT: 9 FR X 4 1/8IN (10 CM)/ASK-09903-HH2; PSI KIT: 9 FR X 10 CM/ASK-09903-LMDTG; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU5; PSI KIT: 9 FR X 10 CM/CDC-09903-1A; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-KSF2; MAC TWO LUMEN/PSI KIT: 9 FR X 11.5 CM/ASK-11242-KSF1 AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-MCY1; MULTI LUMEN PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU4; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/ASK-21242-UCD1; 2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-HHC MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDT; PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-CCH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-MM2; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29903-DU1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-HHC; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDT; PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-NWM; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-SL1; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XCN1A; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-HF6; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29804-HHN1; MULTI LUMEN/MAC KIT: 9 FR X 4 IN (10 CM)/ASK-21142-YWH;

Z-2393-2026

Recall number: Z-2393-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 72,354

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): ASK-09701-UP/10801902143874, 10801902193275/33F23K0811, 33F24B0340, 33F24E0524, 33F24G0489, 33F25C0874, 33F25E1018, 33F25H0747, 33F25J0795, 33F26A0402, 33F26B0243, 33F26B1031; ASK-09803-OSU5/10801902193275/33F25D0761, 33F25E0533, 33F25M0683; ASK-09807-UC/10801902145847, 10801902193275/33F24B0018, 33F24F0004, 33F24J0478, 33F25C0175, 33F25E0210, 33F25E1208, 33F25G0676, 33F25L0211; ASK-09903-HH2/10801902193275/33F25E0534, 33F25G0167, 33F25H0565, 33F25J0358, 33F25M0234, 33F26C0332; ASK-09903-LMDTG/10801902193275/33F25E1184, 33F25F0112, 33F25H0375; ASK-09903-OSU5/10801902193275/33F25D0762; CDC-09903-1A/60801902116729, 10801902193275/33F24D0504, 33F24F0227, 33F24H0267, 33F24H0434, 33F24J0219, 33F24K0023, 33F24M0015, 33F24M0109, 33F25B0006, 33F25B0067, 33F25C0417, 33F25D0696, 33F25D0718, 33F25E1148, 33F25F0023, 33F25G0445, 33F25G0513, 33F25G0605, 33F25G0668, 33F26A1644; ASK-11242-KSF2/10801902193275, 10801902222500/33F25D0231, 33F25D0468, 33F25E0592, 33F25K0131, 33F26A1360, 33F26B0425; ASK-11242-KSF1/10801902193275/33F24L0840, 33F25B0190; ASK-21142-NWM/10801902193275, 10801902222746/33F25F0007, 33F25F0173, 33F25J0207, 33F25M0008, 33F26A1438, 33F26B0197; ASK-21242-MCY1/10801902193275, 10801902221022/33F24H0123, 33F25C0342, 33F25E0671, 33F25K0138, 33F26B0441; ASK-21242-OSU4/10801902193275, 10801902222562/33F25D0757, 33F25E0672, 33F25H0445, 33F25H0651, 33F25L0230, 33F26B0795; ASK-21242-UCD1/10801902193275, 10801902221633/33F25E0314, 33F25M0681, 33F26B0138; ASK-21142-HHC/10801902193275, 10801902211450/33F24L0309, 33F25C0273, 33F25G0170, 33F25H0440, 33F25J0372, 33F26B0125; ASK-21242-LMDT/10801902193275, 10801902220698/33F25C0696, 33F25E0544, 33F26A1526, 33F26B0464; ASK-09804-CCH/10801902141023, 10801902193275/33F24D0899, 33F24F0836, 33F24L0295, 33F25B0184, 33F25C0261, 33F25E0777, 33F25G0410, 33F25J0356, 33F26A1369, 33F26C0041; ASK-29803-MM2/10801902193275, 10801902221930/33F25E0549, 33F26A1352, 33F26B0176, 33F26C0031; ASK-29903-DU1/10801902193275/33F24H0139, 33F25A0171, 33F25E0553, 33F25H0426, 33F25M0012; ASK-29903-HHC/10801902193275/33F25D0235, 33F25L0263, 33F26A1431; ASK-29903-LMDT/10801902193275/33F25D0480, 33F25K0208, 33F25K0420; ASK-29903-NWM/10801902193275/33F25F0008, 33F25F0098, 33F25L0264, 33F26A1396; ASK-29903-SL1/10801902193275/33F25C0289, 33F25G0296, 33F25J0104, 33F25J0266, 33F26A1391; CDC-29803-XCN1A/10801902193114, 10801902193275/33F24E0214, 33F24F0024, 33F24F0173, 33F24F0248, 33F24G0163,33F24H0396, 33F24H0431, 33F24L0539, 33F24M0036, 33F24M0113, 33F25A0368, 33F25B0047, 33F25B0118, 33F25B0342, 33F25C0531, 33F25D0708, 33F25D0735, 33F25E1103, 33F25E1154, 33F25F0417, 33F25G0053, 33F25G0514, 33F25H0287, 33F25H0816, 33F25K0293, 33F25L0079, 33F26A1628, 33F26B0565, 33F26C0064, 33F26C0454, 33F26C0099; ASK-29803-HF6/10801902200478,10801902193275/33F24D0625, 33F24F0889, 33F24L0246, 33F25B0441, 33F25D0268, 33F25F0180, 33F25J0151, 33F25M0832; ASK-29804-HHN1/10801902193275/33F25B0236, 33F25E0550, 33F25G0691, 33F25K0053; ASK-21142-YWH/10801902135473/33F25A0440, 33F25D0030;

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 32 of 35

Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A; AM/AT PI MIDLINE 2L: 5.5FR X 15CM/CDC-41552-MPK1A; AGBA PI MIDLINE 1L: 4.5FR X 15CM/ASK-41541-VFHM; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPK; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKB; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKC; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPK; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKB; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKC; PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPK; PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPKB; PI MIDLINE 1L: 4FR X 20CM/CDC-32041-MPKC; PI MIDLINE 2-L: 5FR X 20CM/CDC-32052-MPKB; PI PICC NaviCurve: 1L 4FR x 55CM w BP/DLX-35541-CURVB; PI PICC: 1L 4FR x 55CM w Biopatch/DLX-35541-HPKB; PI PICC: 1L 4FR x 55CM w CHG/DLX-35541-HPKC; PI PICC: 2L 5FR x 55CM w Biopatch/DLX-35552-HPKB; PI PICC: 2L 5FR X 55CM w CHG/DLX-35552-HPKC; PI PICC: 3L 6FR x 55CM w Biopatch/DLX-35563-HPKB; AGBA PICC/DELTA KIT: 1L 4.5 FR X 40 CM/ASK-44041-NS; AGBA PICC/DELTA FG: 2L 5.5 FR X 40 CM/ASK-44052-NS; AGBA PICC/DELTA KIT: 1L 4.5 FR X 50 CM/ASK-45041-NS; PI PICC KIT: 2L 5.5 FR X 50 CM/ASK-45052-TG; PI AGBA PICC KIT: 3L 6 FR X 50 CM W/VPS/ASK-45063-NS; PICC KIT: 1L 4.5 FR X 55 CM CG+ VPS/ASK-45541-RH; AGBA PICC: 1L 4.5FR x 55CM w Teg CHG/DLX-45541-HPKC; AGBA PICC: 2L 5.5FR x 55CM w Teg CHG/DLX-45552-HPKC; AGBA PICC NaviCurve: 3L 6FR x 55CM TCG/DLX-45563-CURVC; AGBA PICC: 3L 6FR x 55CM w Biopatch/DLX-45563-HPKB; AGBA PICC: 3L 6FR x 55CM w Teg CHG/DLX-45563-HPKC; PI PICC KIT: 1-L 4 FR X 55 CM TIPTRACKER/CDC-35541-TTS; PI PICC NaviCurve: 1L 4FR x 55CM w CHG/DLX-35541-CURVC; PI PICC G4 Stylet: 1L 4FR x 55CM w BP/DLX-35541-VPSB; PI PICC NaviCurve: 2L 5FR x 55CM w CHG/DLX-35552-CURVC; PI PICC G4 Stylet: 2L 5FR x 55CM w BP/DLX-35552-VPSB; PI PICC G4 Stylet: 2L 5FR x 55CM w CHG/DLX-35552-VPSC; PI PICC NaviCurve: 3L 6FR x 55CM w CHG/DLX-35563-CURVC; PI PICC G4 Stylet: 3L 6FR x 55CM w CHG/DLX-35563-VPSC; AGBA PICC/DELTA KIT: 1-L 4.5 FR X 40 CM/CDC-44041-VPS2; PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UWH1; PI AGBA PICC KIT: 2L 5.5FR X 55CM W/ VPS/ASK-45552-UWH1; AGBA PICC G4 Stylet: 1L 4.5FR x 55CM BP/DLX-45541-VPSB; ACCESS TRAY/ASK-04001-NWM; ACCESS TRAY/ASK-04001-VCUH3; PI PICC:1L 4FR X 40CM PRELOAD VPS STYLET/CDC-34041-VPS; PI PICC:2L 5FR X 50CM PRELOAD VPS STYLET/CDC-35052-VPS; ACCESS KIT/ASK-04001-BWK2; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU11; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PVD; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16CM/ASK-12703-LMDTG1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8IN/ASK-15703-ECMC4; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-15703-PNM; CVC KIT: 3 LUMEN 12 FR X 6IN/ASK-22123-UAB; 2-L CVC KIT: 4 FR X13 CM/CDC-24402-X1A; LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-X1A; CVC KIT: 3L 7 FR X 16 CM/ASK-42703-CPR; CVC KIT: 2L 8 FR X 6 IN (16 CM) AGB+/ASK-42802-DMC2; CVC KIT: 2 LUMEN 8 FR X 8 IN (20 CM)/ASK-45802-PCMH1; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-MM1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHUMC1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMSG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU3; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PSAU1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-RHR1; PI CATHETER 2L: 8 FR X 16 CM AGB+/ASK-42802-DU1; PI CVC KIT: 2L 8 FR X 6 IN/ASK-42802-PHF4; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PHHN1; MULTILUMEN CVC KIT: 2L 8 FR X 6 IN/ASK-42802-POSU3; PI CVC KIT: 2-L 8 FR X 16 CM AGB+/ASK-42802-PUCD1; MULTI-LUMEN CVC KIT:2-L 8FR X 6IN (16CM)/ASK-42802-PWHC1; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-UHC; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-MCY1; PI CVC KIT: 3L 7FR X 8IN (20 CM) AGB+/ASK-45703-BCH; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-EMC; PI CVC KIT: 3 LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-MHMC1; PI CVC KIT: 3-L 7 FR X 20 CM AGB+/ASK-45703-NWM; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PCOR; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PIMH; MULTI LUMEN CVC KIT: 3L

Z-2394-2026

Recall number: Z-2394-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 177,014

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): CDC-02031-MK1A/10801902193275/33F25C0444; CDC-41541-MPK1A/10801902193275/33F24L1137; CDC-41552-MPK1A/10801902193275, 50801902130162/33F24L0382, 33F25A0315, 33F25B0630, 33F25K0421, 33S24B0571; ASK-41541-VFHM/10801902193275, 10801902218862/33F24L1080, 33F25B0475, 33F25C0351, 33F25D0404, 33F25E0556, 33F25E0784, 33F25F0186, 33F25J0218, 33F25K0077, 33F25K0100, 33F25M0182, 33F26A1549, 33F26B0823; CDC-41541-MPK/10801902193275, 10801902193275/33F25H0768, 33S23K0382; CDC-41541-MPKB/10801902193275, 10801902205411/33F24H0429, 33F24K0043, 33F24M0067, 33F24M0149, 33F25A0390, 33F25B0099, 33F25B0343, 33F25C0578, 33F25E0421, 33F25F0401, 33F25G0515, 33F25G0710, 33F25H0817, 33F25J1008, 33F25L0015, 33F25L0050, 33F25L0295, 33F25M0499, 33F26A0330, 33X25J0003; CDC-41541-MPKC/10801902205435, 10801902193275/33F24D0982, 33F24F0166, 33F24F0167, 33F24H0398, 33F24H0454, 33F24J0380, 33F24J0389, 33F24K0581, 33F24L0182, 33F24M0022, 33F24M0077, 33F25A0348, 33F25B0228, 33F25B0281, 33F25B0289, 33F25B0344, 33F25C0513, 33F25C0532, 33F25C0558, 33F25D0710, 33F25D0736, 33F25F0020, 33F25F0025, 33F25F0032, 33F25H0818, 33F25J0577, 33F25J0657, 33F25L0251, 33F25L0296, 33S25A0211, 33F26C0435; CDC-41552-MPK/10801902201505/33F24D0561, 33F26B0490, 33S24A0521; CDC-41552-MPKB/10801902193275, 10801902205428/33F24J0183, 33F24J0221, 33F24L0010, 33F24L0173, 33F24M0114, 33F25B0223, 33F25B0299, 33F25D0724, 33F25F0436, 33F25G0640, 33F25K0354, 33F25L0265, 33F26B1048; CDC-41552-MPKC/10801902205442, 10801902193275/33F24C0861, 33F24D0343, 33F24F0090, 33F24K0474, 33F25C0208, 33F25D0559, 33F25E0827, 33F25H0608, 33F25J0434, 33F25M0248, 33F26A1559, 33F26C0776; CDC-32041-MPK/10801902193275, 10801902201475/33F25C0701, 33F25H0613, 33F25J0433, 33F25L0115, 33F25M0250, 33F26B0436; CDC-32041-MPKB/10801902205398, 10801902193275/33F24D0854, 33F24F0897, 33F24L0952, 33F25B0502, 33F25D0512, 33F25E0825, 33F25G0327, 33F25J0327, 33F25M0210, 33F26B0434, 33S23E0870; CDC-32041-MPKC/10801902193275/33F25D0513, 33F25H0590, 33F26A1387; CDC-32052-MPKB/10801902205404, 10801902193275/33F24F0825, 33F24L0381, 33F25D0514, 33F25H0609; DLX-35541-CURVB/10801902193275, 10801902208757/33F25D0674, 33F25J0186, 33S23G0883, 33S23H0988; DLX-35541-HPKB/10801902193275/33F25D0129, 33F25E0708; DLX-35541-HPKC/10801902193275/33F25D0244, 33F25E0830; DLX-35552-HPKB/10801902193275/33F25D0246, 33F25D0518, 33F25F0149; DLX-35552-HPKC/10801902193275, 10801902216721/33F25D0247, 33F25D0519, 33F25H0460, 33S23K0380; DLX-35563-HPKB/10801902193275/33F25K0318; ASK-44041-NS/10801902193275, 10801902216462/33F24L0347, 33S23H0298; ASK-44052-NS/10801902193275, 10801902216455/33F25A0302, 33S23J0265; ASK-45041-NS/10801902216677/33S24A0529; ASK-45052-TG/10801902193275/33F24L0864, 33F25D0409, 33F25H0490, 33F26A1379; ASK-45063-NS/10801902193275/33F24L1002; ASK-45541-RH/10801902193275/33F25B0574, 33F25E0607, 33F25H0427, 33F25J0161, 33F26A1412; DLX-45541-HPKC/10801902208849, 10801902193275/33F24D0604, 33F25D0128, 33F25E0763, 33F25J0131, 33F25M0315, 33F26B0456; DLX-45552-HPKC/10801902208856, 10801902193275/33F24F0097, 33F25C0450, 33F25D0252, 33F25D0625, 33F25G0321, 33F25H0601, 33F26B0213; DLX-45563-CURVC/10801902193275, 10801902208740/33F25A0321, 33F25B0635, 33F25D0522, 33F25E0766, 33F25G0394, 33F26C0707; DLX-45563-HPKB/10801902193275/33F25D0384, 33F25F0226; DLX-45563-HPKC/10801902208863, 10801902193275/33F24D0184, 33F25B0698, 33F25E0661, 33F26A1545; CDC-35541-TTS/10801902193275/33F25B0468; DLX-35541-CURVC/10801902193275, 10801902216684/33F25D0574, 33F25E0759, 33F25G0216, 33F25H0591, 33F25M0200, 33F26B0192; DLX-35541-VPSB/10801902193275, 10801902208665/33F25C0212, 33F25D0378, 33F25E0831, 33F25F0101, 33F25G0364, 33F25J0128, 33F25J0256, 33F25K0193, 33F25M0164, 33F26A1131, 33F26B0180, 33F26C0699; DLX-35552-CURVC/10801902193275, 10801902216714/33F25C0373, 33F25D0619, 33F25F0222, 33S24C0282; DLX-35552-VPSB/10801902193275, 10801902208672/33F25B0536, 33F25D0248, 33F25D0379, 33F25D0575, 33F25H0471, 33F25H0603, 33F26C0042; DLX-35552-VPSC/10801902193275, 10801902216738/33F25B0389, 33F25D0249, 33F25J0122, 33F25J0335, 33F25M0445, 33F26A0470, 33S24B0733; DLX-35563-CURVC/10801902193275, 10801902216745/DLX-35563-CURVC, DLX-35563-CURVC, DLX-35563-CURVC; DLX-35563-VPSC/10801902193275, 10801902216769/33F25C0395, 33F26B0380; CDC-44041-VPS2/10801902193275, 50801902120699/33F24K0430, 33S23L0922; ASK-45541-UWH1/10801902193275, 10801902217216/33F24L0991, 33F25C0198, 33F25E0572, 33F25H0457, 33F25J0400, 33F25M0151, 33F26B0384; ASK-45552-UWH1/10801902193275/33F24L0431, 33F25B0576, 33F25G0212, 33F25H0589, 33F25J0225, 33F25M0229, 33F26A1554; DLX-45541-VPSB/10801902193275, 10801902208603/33F24L1122, 33F25B0679, 33F25D0064, 33F25D0521, 33F25H0403, 33F25H0605, 33F26C0119; ASK-04001-NWM/10801902193275, 10801902222715/33F25F0005, 33F25F0125, 33F26A1493, 33F26B0829; ASK-04001-VCUH3/10801902214895, 10801902193275/33F24D0895, 33F24F0785, 33F24L1087, 33F25B0172, 33F25F0161, 33F25G0221, 33F25H0522, 33F25J0198, 33F26B0228, 33F26B0831, 33F26C0534; CDC-34041-VPS/10801902193275/33F24L0236; CDC-35052-VPS/10801902193275/33F25E0425; ASK-04001-BWK2/10801902193275/33F25A0226, 33F25D0389, 33F25E0519, 33F25F0076, 33F25F0139, 33F25H0660, 33F25J0347, 33F26A1341; ASK-04001-DU11/10801902193275/33F25C0425, 33F25D0328, 33F25F0140, 33F25H0506; ASK-42703-PVD/10801902156966, 10801902193275/33F24F0977, 33F24L1004, 33F25C0302, 33F25K0144, 33F26B0157; ASK-12703-LMDTG1/10801902193275, 10801902205688/33F25D0262, 33F25G0280, 33F26B0212; ASK-15703-ECMC4/10801902159950, 10801902193275/33F24E0649, 33F24F1039, 33F25B0439; ASK-15703-PNM/10801902193275/33F25E0312; ASK-22123-UAB/10801902144956, 10801902193275/33F24F0854, 33F24L0318, 33F25C0281, 33F25D0267, 33F25D0593, 33F25J0380; CDC-24402-X1A/10801902193275, 10801902168099/33F24L1111, 33F25C0206, 33F25E0747, 33F25G0341, 33F25H0554, 33F25J0324, 33F26A1561, 33F26B0165, 33F26B0803; CDC-25123-X1A/10801902193275, 10801902168105/33F25B0675, 33F25D0501, 33F25E0887, 33F25G0379, 33F26A1562, 33F26B0892; ASK-42703-CPR/10801902193275, 10801902135220/33F25C0744, 33F25E0234, 33F25J0559, 33F25J0797, 33F25K0401, 33F26B0244; ASK-42802-DMC2/10801902193275/33F25E0005; ASK-45802-PCMH1/10801902193275/33F25D0034; ASK-42703-MM1/10801902193275, 10801902221916/33F25E0509, 33F25E0559, 33F25M0205, 33F25M0449, 33F26A1659, 33F26B0196; ASK-42703-PHUMC1/10801902193275/33F25E0009, 33F25G0174, 33F25G0682, 33F25L0138, 33F26A0234; ASK-42703-PMSG1/10801902193275/33F25F0363; ASK-42703-POSU3/10801902193275, 10801902222579/33F25D0758, 33F25E0563, 33F25L0109, 33F26A1436, 33F26B0782; ASK-42703-PSAU1/10801902193275, 10801902159486/33F25A0258, 33F25C0300, 33F25D0543, 33F25J0108, 33F25J0273, 33F25M0093, 33F26B0758; ASK-42703-RHR1/10801902193275, 10801902163643/33F25E0311, 33F25G0262, 33F25H0425, 33F25L0060, 33F26A0238, 33F26C0483; ASK-42802-DU1/10801902161007, 10801902193275/33F24C0924, 33F24F0870, 33F24L0870, 33F25D0356, 33F25E0566, 33F25F0191, 33F25J0285, 33F26B0423; ASK-42802-PHF4/10801902200485, 10801902193275/33F24F0759, 33F25B0357, 33F25B0478, 33F25E0568, 33F25F0079, 33F25G0176, 33F25J0392, 33F25M0059, 33F26A1528, 33F26B0190, 33F26B0793; ASK-42802-PHHN1/10801902193275/33F25E0004, 33F25G0265, 33F25K0045, 33F25M0065; ASK-42802-POSU3/10801902193275, 10801902222586/33F25D0759, 33F25E0569, 33F25F0193, 33F25G0186, 33F25J0393, 33F26A1548, 33F26B0859; ASK-42802-PUCD1/10801902193275/33F25E0313, 33F25E1206; ASK-42802-PWHC1/10801902193275, 10801902134858/33F25B0498, 33F25E0680, 33F25F0195, 33F25J0160, 33F26B0418, 33F26C0164; ASK-42802-UHC/10801902193275, 10801902159745/33F25C0306, 33F25E0605, 33F25J0289, 33F26B0200; ASK-42854-MCY1/10801902193275, 10801902220995/33F24H0126, 33F24J0099, 33F25B0479, 33F25E0570, 33F25F0196, 33F25J0396, 33F26B0779; ASK-45703-BCH/10801902193275, 10801902222784/33F25F0004, 33F25F0117, 33F25G0184, 33F25G0185, 33F25H0508, 33F26A1381, 33F26B0876; ASK-45703-EMC/10801902160468, 10801902193275/33F24D0579, 33F24L0911, 33F25D0411, 33F25G0406, 33F25M0181, 33F26C0225; ASK-45703-MHMC1/10801902193275, 10801902213850/33F25B0580, 33F25D0366, 33F25E0574, 33F25G0224, 33F25H0463, 33F25J0231, 33F26B0129; ASK-45703-NWM/10801902193275/33F25F0006, 33F25F0105, 33F25M0009, 33F26A1463; ASK-45703-PCOR/10801902193275/33F24L0088, 33F25C0736, 33F25H0755; ASK-45703-PIMH/10801902193275/33F25B0588; ASK-45703-PK/10801902193275/33F25A0271, 33F25E0623; ASK-45703-PLGH2/10801902144536, 10801902193275/33F24D0901, 33F24F0995, 33F24L0213, 33F24L0964, 33F25C0315; ASK-45703-PMM4/10801902193275/33F25A0272; ASK-45703-PMM5/10801902193275, 10801902221947/33F25E0505, 33F25E0624, 33F25G0192, 33F25L0105, 33F25L0269, 33F26A1368, 33F26B0207, 33F26C0153; ASK-45703-POSU3/10801902193275, 10801902222593/33F25D0760, 33F25E0576, 33F25E0686, 33F25M0097, 33F26A1346, 33F26B0148, ASK-45703-PPHP1/10801902193275/33F24K0067, 33F25C0584, 33F25G0555, 33F26A0240; ASK-45703-PSAM/10801902116373, 10801902193275/33F24E0560, 33F24G0518, 33F24J0638, 33F25C0818, 33F25G0144, 33F25J0931, 33F26B0509; ASK-45703-PUCD1/10801902193275, 10801902221640/33F25D0237, 33F25D0607, 33F25H0653, 33F25K0159, 33F25M0228, 33F26A1499, 33F26B0374; ASK-45703-PUNCC2/10801902164268, 10801902193275/33F24D0696, 33F24F0690, 33F24K0439, 33F25B0598,33F25D0373, 33F25E0690, 33F25F0147, 33F25H0204, 33F25H0631, 33F25J0233, 33F26B0415; ASK-45854-PAMC1/10801902193275/33F25C0363, 33F25H0519, 33F25K0162, 33F26A0524; ASK-45854-PLGH1/10801902193275/33F24L0191, 33F25B0361, 33F25E0309, 33F25H0775, 33F26A0247; CDC-45802-XPN1A/10801902193275/33F25A0290, 33F25B0632, 33F25E0757, 33F25J0255, 33F26A1565; CDC-42703-XPN1A/10801902193275, 10801902162066/33F25F0069, 33F25F0332, 33F25H0879, 33F25H0881, 33F25J0224, 33F25J0693, 33F25J0697, 33F25J0717, 33F25J0721, 33F25L0014, 33F25L0250, 33F25M0019, 33F25M0028,33F26A0312, 33F26A0338, 33F26B0624, 33F26C0066, 33F26C0074, 33F26C0087, 33F26C0101, 36F25A0010, 36F25B0035, 36F25B0038, 36F25B0069, 36F25E0017, 36F25G0013, 36F25H0001, 36F25H0002, 36F25H0026, 36F25J0003; CDC-45703-PB1A/10801902117202, 10801902193275/33F24C1072, 33F24E0626, 33F24F0945, 33F25E0754, 33F25G0581, 33F25H0435, 33F25J0118, 33F25J0328; CDC-45854-P1A/30801902117275/33F24D0700, 33F24F0086, 33F24F0794, 33F25C0210, 33F25D0571, 33F25E0705, 33F25G0276, 33F25H0444, 33F25J0121, 33F25J0184, 33F25K0191, 33F26A1558, 33F26B0886;

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 33 of 35

Description/REF: PICC ACCESS TRAY/ASK-04001-CG1

Z-2395-2026

Recall number: Z-2395-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 360

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): ASK-04001-CG1/10801902193275/33F25C0224, 33F25D0647, 33F25G0390, 33F25J0348

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 34 of 35

Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-04711

Z-2396-2026

Recall number: Z-2396-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 35,540

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): AK-04210/10801902121582, 10801902193275/33F24A1009, 33F24B0106, 33F24C0009, 33F24D0014, 33F24G0324, 33F24J0490, 33F24K0089, 33F24L0671, 33F25A0456, 33F25C0899, 33F25E0037, 33F25H0011, 33F25J0461; AK-04300/10801902121636, 10801902193275/33F24A1257, 33F24B0435, 33F24C0734, 33F24E0704, 33F24F0011, 33F24G0224, 33F24G0684, 33F24H0373, 33F24M0148, 33F25A0364, 33F25B0084, 33F25D0193, 33F25D0693, 33F25E0479, 33F25H0686, 33F25J0587, 33F25J0651, 33F26C0397; CK-04711/20801902118787, 10801902193275/33F24A0137, 33F24A1212, 33F24B0382, 33F24C0255, 33F24E0572, 33F24G0531, 33F24J0648, 33F24L0731, 33F25A0590, 33F25C0979, 33F25E1039, 33F25J0622, 33F26B0640

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

device · product 35 of 35

Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-UPM; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-HC; ARTERIAL LINE KIT: 20 GA X 5IN (12 CM)/ASK-04020-HMC; RADIAL ARTERY CATHETER KIT: 20 GA X 30MM/ASK-04020-MMC; RA CATH KIT: 20 GA X 1-1/2IN (3.81 CM)/ASK-04020-SV; ARTERIAL CATH KIT: 20 GA X 5 IN (12 CM)/ASK-04100-AMC-S1; ARTERIAL CATHETER KIT: 20 GA X 12 CM/ASK-04100-NS; RADIAL ARTERY KIT/ASK-04500-AH; RAD ART:20GAX3.81CM / ART LINE:20GAX12CM/ASK-04500-HF-S; ARTERIAL LINE KIT: 1L 20 GA X 12 CM/ASK-04510-HA; ARTERIAL LINE KIT: 20 GA. X 5 IN (12 CM)/ASK-04510-HF; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-IHC1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-MSK2; ARTERIAL CATH KIT: 20GA X 5IN/ASK-04510-NS; ARTERIAL CATHETER KIT: 20 GA X 12 CM/FS-04510-S; ARTERIAL LINE KIT/HF-04510-1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-BSM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45CM)/ASK-04020-HH1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-JMH1; RA CATH KIT: 20 GA X 1-3/4 IN/ASK-04020-MAS; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-MCC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MHT; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MI; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MIHS; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MUSC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-NCB; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-SPH; RA CATH SET: 20 GA X 1-3/4IN (4.45CM)/ASK-04020-UPM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UR1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-X1A; RA CATH KIT: 20 GA X 1-3/4IN/WBH-04020-1; CVC KIT: 20 GA X 12CM/ASK-04510-UCLA; ARTERIAL ACCESS TRAY WITH .025IN SWG/ASK-04001-BW1

Z-2397-2026

Recall number: Z-2397-2026
Initiated: April 21, 2026
Classification: Class I
Status: Ongoing
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 310,606

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Code information

REF(Material)/UDI-DI/Lot(Batch): NA-04220-1A/10801902193275/33F26B0027; NA-04220-X1A/10801902193275/33F24G0553, 33F25E0272, 33F25E1053, 33F25H0760, 33F25J0636; ASK-04018-HCA/10801902119268/33F24A0078; ASK-04018-UPM/50801902117644, 10801902193275/33F23B0953, 33F24A0389, 33F24B0140, 33F24D0028, 33F24H0480, 33F24J0550, 33F24K0164, 33F25A0505, 33F25C0742, 33F25C0792, 33F25E0961, 33F25E1070, 33F25E1071, 33F25E1072, 33F25G0105, 33F25H0062, 33F25J0866, 33F25L0353, 33F26B0507; ASK-04020-HC/10801902121384, 10801902193275/33F24A0828, 33F24B0246, 33F24C0148, 33F24D0113, 33F24G0409, 33F24J0559, 33F24K0172, 33F24L0693, 33F25C0136, 33F25C0933, 33F25E0128, 33F25H0070, 33F25L0356; ASK-04020-HMC/10801902117691, 10801902193275/33F24A0324, 33F24A0743, 33F24B0248, 33F24C0150, 33F24D0115, 33F24H0475, 33F24K0174, 33F24L0802, 33F25H0072, 33F25J0872, 33F25L0395, 33F26B0650, 33S24A0743, 33S24C0150, 33F26B0673; ASK-04020-MMC/10801902117769, 10801902193275/33F24C0160, 33F24D0123, 33F24E0423, 33F24G0420, 33F24H0487, 33F24J0571, 33F24K0183, 33F24L0692, 33F25A0523, 33F25C0974, 33F25E0139, 33F25H0081, 33F25J0880, 33F25L0346, 33F25M0853; ASK-04020-SV/10801902117837, 10801902117837/33F24A0868, 33F24B0269, 33F24E0436, 33F24E0437, 33F24L0746, 33F25H0087, 33F25J0885, 33F26B0512; ASK-04100-AMC-S1/10801902124927, 10801902193275/33F24D0139, 33F24E0446, 33F24G0439, 33F24K0199, 33F25A0532, 33F25E0153, 33F25G0116, 33F25H0093, 33F25J0516, 33F26B0656; ASK-04100-NS/10801902193275, 10801902117929/33F24G0440, 33F24L0579, 33F24M0266, 33F25A0533, 33F25C0151, 33F25C0788, 33F25E0155, 33F25H0095, 33F25J0518, 33F25K0256, 33F25L0448, 33F25M0945, 33F26B0649, 33F26B0667; ASK-04500-AH/10801902114041, 10801902193275/33F24A0153, 33F24A0803, 33F24B0282, 33F24C0181, 33F24E0452, 33F24G0444, 33F24J0586, 33F25A0538, 33F25H0101, 33F25J0893; ASK-04500-HF-S/10801902118001, 10801902193275/33F24A0141, 33F24A0753, 33F24A1157, 33F24B0283, 33F24C0182, 33F24D0143, 33F24E0453, 33F24G0445, 33F24J0587, 33F24K0206, 33F24L0766, 33F25C0154, 33F25C0966, 33F25E0161, 33F25H0102, 33F25J0894, 33F25L0492, 33R25C0966; ASK-04510-HA/10801902193275/33F24J0591, 33F24K0210, 33F25B0685, 33F25C0911, 33F25E0166, 33F25E0993, 33F25J0524, 33F25L0449; ASK-04510-HF/10801902193275, 10801902118025/33F24G0450, 33F24J0305, 33F24K0211, 33F24L0543, 33F24L0558, 33F25A0540, 33F25C0896, 33F25E0167, 33F25G0119, 33F25H0104, 33F25J0525, 33F25K0412, 33F25L0339, 33F26B0648, 33F26B0666, 33F26C0588; ASK-04510-IHC1/10801902193275/33F24J0306, 33F24L0699, 33F25C0157, 33F25C0782, 33F25E0168, 33F25H0105, 33F25L0475; ASK-04510-MSK2/10801902118049, 10801902193275/33F24A0872, 33F24B0290, 33F24D0150, 33F24E0461, 33F24G0453, 33F24J0594, 33F25A0541, 33F25C0852, 33F25E0170, 33F25H0740; ASK-04510-NS/10801902193275, 10801902224177/33F25K0324, 33F26B0653; FS-04510-S/10801902193275, 10801902119824/33F24L0738, 33F25C0188, 33F25C0755, 33F25L0426, 33F26B0657; HF-04510-1/10801902119855, 10801902193275/33F24D0036, 33F24G0537, 33F24J0652, 33F24L0576, 33F25A0593, 33F25C0897, 33F25E0260, 33F25E1044, 33F25H0166, 33F25J0936, 33F26B0652, 33F26B0675; ASK-04020-BSM/10801902193275/33F24J0365, 33F24M0075, 33F25A0079, 33F25B0312, 33F25D0116, 33F25D0297, 33F25E0367, 33F25F0400, 33F25G0653, 33F25J0983, 33F25L0155; ASK-04020-HH1/10801902193275, 10801902128536/33F24K0173, 33F24L0729, 33F25C0137, 33F25C0914, 33F25E0129, 33F25H0071, 33F25J0871, 33F25L0420, 33F26B0563; ASK-04020-JMH1/10801902114089, 10801902193275/33F24A0792, 33F24C0152, 33F24D0117, 33F24E0416, 33F24H0481, 33F24J0562, 33F24L0775, 33F25A0515, 33F25C0139, 33F25C0970, 33F25E0975, 33F25H0074, 33F25J0875, 33F25L0330, 33F26A0969; ASK-04020-MAS/10801902193275/33F25K0032; ASK-04020-MCC/10801902193275/33F24K0063, 33F24M0043; ASK-04020-MHT/10801902117721, 10801902193275/33F24A0094, 33F24B0019, 33F24D0052, 33F24D0966, 33F24J0475, 33F24L0083, 33F25C0739, 33F25E0980, 33F25F0529, 33F25J0506, 33F25K0329, 33F26A0403, 33F26C0056, 33F26C0260; ASK-04020-MI/10801902193275/33F24K0549, 33F25A0521, 33F25E1149, 33F25F0453, 33F25G0679, 33F25H0079, 33F25H0734, 33F25J0794, 33F25K0327, 33F25L0207, 33F25M0689, 33F26A0398; ASK-04020-MIHS/10801902193275/33F25A0442, 33F25B0233, 33F25C0379, 33F25D0035, 33F25H0494, 33F25K0426; ASK-04020-MUSC/10801902117776, 10801902193275/33F24A0751, 33F24A1138, 33F24B0259, 33F24C0162, 33F24D0125, 33F24E0425, 33F24G0421, 33F24K0184, 33F24L0640, 33F25C0141, 33F25C0830, 33F25E0140, 33F25H0083, 33F25J0881, 33F26B0575; ASK-04020-NCB/10801902117783, 10801902193275/33F24A0864, 33F24B0260, 33F24C0163, 33F24E0426, 33F24G0422, 33F24J0572, 33F24K0185, 33F24L0711, 33F25C0921, 33F25E0141, 33F25H0084, 33F25J0508, 33F25M0857; ASK-04020-PMC/30801902158896, 10801902193275/33F24F0095, 33F24L0242; ASK-04020-SPH/10801902193275/33F25C0143, 33F25C0977, 33F25E0985, 33F25H0735, 33F26A1075; ASK-04020-UPM/10801902117851, 10801902193275/33F24A0255, 33F24A0385, 33F24A1037, 33F24B0141, 33F24C0033, 33F24E0095, 33F24G0434, 33F24J0299, 33F24K0195, 33F24L0578, 33F25A0529, 33F25C0147, 33F25C0898, 33F25E0149, 33F25H0090, 33F25J0886, 33F25L0405, 33F26B0553; ASK-04020-UR1/10801902193275/33F24K0196, 33F24L0748, 33F25C0148, 33F25C0850, 33F25E0150, 33F25G0114, 33F25L0460, 33F25M0953; NA-04020-X1A/10801902193275, 30801902119927/33F24J0683, 33F24K0295, 33F24L0575, 33F24L0784, 33F25A0601, 33F25A0622, 33F25C0951, 33F25E0271, 33F25E1051, 33F25G0153, 33F25H0178, 33F25J0634, 33F25J0941, 33F25K0322, 33F25K0323, 33F25L0327, 33F25M0837, 33F26B0491; WBH-04020-1/10801902162943, 10801902193275/33F24B0465, 33F24C0787, 33F24E0780, 33F24G0659, 33F24J0435, 33F25A0124, 33F25B0054, 33F25B0110, 33F25B0227, 33F25C0404, 33F25C0522, 33F25E1163, 33F25G0630, 33F25H0349, 33F25J0080, 33F25L0162, 33F26B0060, 33F26C0408; ASK-04510-UCLA/10801902118070, 10801902193275/33F24C0189, 33F24E0465, 33F24G0455, 33F24K0215, 33F25A0543, 33F25C0861, 33F25E0173, 33F25H0106, 33F25J0897, 33F25L0347; ASK-04001-BW1/10801902117585/33F24D0105, 33F24G0277, 33F24H0240, 33F24J0546, 33F24K0158;

Distribution pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

Event summary

Source snapshots represented here

Every recalled product in this event

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