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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98745

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 10, 2026
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
ARROW INTERNATIONAL, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I

Z-2156-2026
Recall number
Z-2156-2026
Initiated
April 10, 2026
Classification
Class I
Status
Ongoing
Recalling firm
ARROW INTERNATIONAL, LLC
Quantity
285

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

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

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

Code information

REF/UDI-DI/Lot: CS-15242-I/ 30801902195280/33F23G0536; CS-15282-I/30801902195532/33F23C0877, 33F24A0281, 33F24H0041; CS-15322-I/30801902197451/33F23G0545

Distribution pattern

Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW

device · product 2 of 4

Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272-VFI, CS-15272-VFIE, CS-15312-VFI, CS-15312-VFIE, CS-15422-VFI, CS-15422-VFIE, CS-15552-VFI, CS-15552-VFIE; Arrow-Clark VectorFlow Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer: REF: CS-15192-VFIM, CS-15232-VFIM, CS-15272-VFIM; Arrow-Clark VectorFlow Retrograde Chronic Hemodialysis Catheter, REF: ACS-15192-VF, ACS-15232-VF, ACS-15272-VF, ACS-15552-VF, CS-15192-VF, CS-15192-VFE, CS-15232-VF, CS-15232-VFE, CS-15272-VF, CS-15272-VFE, CS-15312-VF, CS-15312-VFE, CS-15422-VF, CS-15422-VFE, CS-15552-VF, CS-15552-VFE; Arrow-Clark VectorFlow Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer: CS-15192-VFM, CS-15232-VFM, CS-15272-VFM

Z-2157-2026
Recall number
Z-2157-2026
Initiated
April 10, 2026
Classification
Class I
Status
Ongoing
Recalling firm
ARROW INTERNATIONAL, LLC
Quantity
92,827

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

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

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

Code information

REF/UDI-DI/Lots: ACS-15192-VFI/ 10801902126709/33F23G0040, 33F25C0689; ACS-15232-VFI/10801902126723/33F23G0045, 33F25C0678; ACS-15272-VFI/ 10801902126747/33F24G0638; CS-15192-VFI/10801902127188, 10801902193572/33F23E0579, 33F23G0042, 33F23K0170, 33F23L0933, 33F24E0271, 33F24G0166, 33F24J0086, 33F24L0064, 33F24M0224, 33F25C0652, 33F25D0052, 33F25D0700, 33F25E1081, 33F25F0015, 33F25F0388, 33F25G0702, 33F25H0785; CS-15192-VFIE/10801902199659/33F23D0853, 33F23E0773, 33F23G0044, 33F23G0532, 33F23H0611, 33F23K0169,33F23K1105,33F23L0934, 33F24A0912, 33F24A0913, 33F24C0058, 33F24D1001, 33F24G0167,33F24G0187, 33F24J0030, 33F24J0032, 33F24J0339, 33F24J0381, 33F24K0659, 33F24L0058, 33F24L0511, 33F24M0155, 33F24M0215, 33F24M0265, 33F25A0143, 33F25A0407, 33F25B0259, 33F25C0037, 33F25D0285, 33F25D0738, 33F25F0060, 33F25G0635; CS-15232-VFI/10801902194463/33F23C0864, 33F23E0578, 33F23E0832, 33F23G0535, 33F23G0840, 33F23H0612, 33F23K0144, 33F24A0914, 33F24C0079, 33F24E0269, 33F24J0042, 33F25B0256, 33F25C0014, 33F25C0709, 33F25C0650, 33F25E1085, 33F25E1130, 33F25F0009, 33F25G0023, 33F25G0450, 33F25H0341, 33F25J1014; CS-15232-VFIE/10801902195149/33F23D0855, 33F23E0774, 33F23G0047, 33F23G0048, 33F23G0049, 33F23K0145, 33F23K0175, 33F23L0938, 33F24A0915, 33F24C0069, 33F24G0169, 33F24J0026, 33F24J0027, 33F24J0028, 33F24J0084, 33F24K0700, 33F24L0178, 33F24M0005, 33F24M0214, 33F24M0219, 33F25C0646, 33F25C0665, 33F25D0097, 33F25E0358, 33F25E0434, 33F25F0012, 33F25F0275, 33F25F0328, 33F25G0069, 33F25H0293, 33F25H0822, 33F25K0235; CS-15272-VFI/10801902193640, 10801902127362/33F23E0871, 33F23F0742, 33F23H0981, 33F23K0181, 33F24A0306, 33F24C0084, 33F24J0062, 33F25D0098, 33F25E0307, 33F25E0332, 33F25E0354, 33F25F0058, 33F25F0245, 33F25J0659; CS-15272-VFIE/10801902195255/33F23E0886, 33F23G0537, 33F23H0982, 33F23K0180, 33F23L0946, 33F24A0922, 33F24C0065, 33F24D1011, 33F24E0686, 33F24E0805, 33F24K0508, 33F24M0223, 33F25A0410, 33F25C0009, 33F25G0717; CS-15312-VFI/10801902197778/33F23G0543, 33F23L0953, 33F24D1007, 33F24E0810, 33F24J0048, 33F25C0039, 33F25D0218, 33F25E0470, 33F25J0021; CS-15312-VFIE/10801902195491/33F23K0183, 33F23L0954, 33F24A0923, 33F24D1013, 33F25A0403, 33F25F0534, 33F25G0722; CS-15422-VFI/10801902193664/33F23G0549, 33F24E0815, 33F25E1074; CS-15422-VFIE/10801902197440/33F23G0550, 33F23K0178, 33F23L0958, 33F24A0919, 33F24C0073, 33F24E0816, 33F25F0303; CS-15552-VFI/10801902193671/33F23K0184, 33F24J0076, 33F25E1075; CS-15552-VFIE/10801902195163/33F23E0865, 33F23F0743, 33F24D0972, 33F24E0819, 33F24G0098, 33F24K0656, 33F25A0032; CS-15192-VFIM/10801902193589/33F24E0792, 33F25C0676, 33F25L0035; CS-15232-VFIM/10801902193619/33F23C0879, 33F23L0939, 33F24A0304, 33F24E0798, 33F24J0047; CS-15272-VFIM/10801902197761/33F23H1027; ACS-15192-VF/10801902126693/33F24G0637; ACS-15232-VF/10801902126716/33F23H1016; ACS-15272-VF/10801902126730/33F23H1024; ACS-15552-VF/10801902126792/33F23H1021; CS-15192-VF/20801902193593/33F23K0186, 33F23L0931, 33F24C0082, 33F24E0788, 33F24J0054, 33F24M0162, 33F24M0230, 33F25D0271; CS-15192-VFE/10801902195460/33F23E0776, 33F23F0728, 33F23G0531, 33F24A0917, 33F24C0063, 33F24D1003, 33F24E0789, 33F24J0039, 33F24L0069, 33F24M0156, 33F24M0159, 33F25C0683, 33F25D0107, 33F25D0220, 33F25E0343, 33F25F0273, 33F25F0462, 33F25G0444, 33F25H0820, 33F25K0384; CS-15232-VF/10801902193626/33F23C0873, 33F23J0546, 33F24A0294, 33F24C0071, 33R24G0168, 33F24J0044, 33F25D0089, 33F25E0333, 33F25E0427, 33F25E1095, 33F25F0404, 33F25H0294, 33F25J1009; CS-15232-VFE/10801902195132/33F23E0775, 33F23F0720, 33F23K0176, 33F23K0194, 33F23L0937, 33F24A0927, 33F24C0059, 33F24D1010, 33F24E0270, 33F24E0796, 33F24G0045, 33F24J0035, 33F24J0083, 33F24L0171, 33F24M0216, 33F25A0004, 33F25A0083, 33F25C0023, 33F25C0659, 33F25D0106, 33F25D0219, 33F25D0726, 33F25E0478, 33F25E1105, 33F25F0298, 33F25J1056, 33F25K0335, 33F25L0011; CS-15272-VF/10801902193657/33F23C0880, 33F23F0740, 33F23L0944, 33F24C0081, 33F24E0804, 33F24J0051, 33F24J0686, 33F24M0228, 33F25C0668, 33F25E0337, 33F25F0403, 33F25J0590; CS-15272-VFE/10801902195248/33F23E0777, 33F23F0732, 33F23H0980, 33F23K0172, 33F23L0945, 33F24A0918, 33F24C0064, 33F24H0044, 33F24H0255, 33F24M0237, 33F25C0049, 33F25E0349, 33F25E1132, 33F25G0637; CS-15312-VF/10801902127447/33F24G0060, 33F25D0216; CS-15312-VFE/10801902195484/33F23F0734, 33F23G0542, 33F23L0952, 33F24A0925, 33F24C0076, 33F24J0053, 33F24M0225, 33F25A0033, 33F25C0667, 33F25E0320, 33F25E0469, 33F25G0603; CS-15422-VF/10801902128666/33F23H1020, 33F25G0734; CS-15422-VFE/10801902197341/33F23G0548, 33F23H0986, 33F23L0957, 33F24A0929, 33F24J0483, 33F24M0229, 33F25C0681, 33F25E0440, 33F25F0250, 33F25G0484; CS-15552-VF/10801902128703/33F23H1012, 33F25C0674, 33F25J0588; CS-15552-VFE/10801902195156/33F23D0868, 33F23G0261, 33F23G0551, 33F23K0173, 33F24A0928, 33F24D1014, 33F24E0818, 33F24J0059, 33F24K0511, 33F25C0670, 33F25E0471, 33F25F0455, 33F25G0447; CS-15192-VFM/10801902193602/33F23K0189, 33F24C0078, 33F24J0049, 33F24M0243, 33F25C0672, 33F25E1077, 33F25F0418; CS-15232-VFM/10801902193633/33F23J0547, 33F24A0289, 33F24C0077, 33F24E0799, 33F24J0045, 33F24J0093, 33F25A0026, 33F25C0050, 33F25E0348, 33F25K0348; CS-15272-VFM/10801902127393/33F25C0687

Distribution pattern

Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW

device · product 3 of 4

Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15242-SPM, CS-15282-SPM, CS-15322-SPM, CS-15362-SPM

Z-2158-2026
Recall number
Z-2158-2026
Initiated
April 10, 2026
Classification
Class I
Status
Ongoing
Recalling firm
ARROW INTERNATIONAL, LLC
Quantity
34,568

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

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

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

Code information

REF/UDI-DI/Lots: CS-15242-VSP/30801902195273/33F23C0870, 33F23D0857, 33F23F0719, 33F23K0182, 33F24A0265, 33F24C0062, 33F24D1000, 33F24D1039, 33F24E0803, 33F24H0038, 33F24H0261, 33F24K0505, 33F24M0039, 33F24M0218, 33F25A0141, 33F25C0657, 33F25D0125, 33F25E0305, 33F25E0429, 33F25E0430, 33F25E1131, 33F25F0042, 33F25G0070, 33F25H0295, 33F25H0366, 33F25H0674, 33F25J1015; CS-15282-VSP/30801902195518/33F23C0866, 33F23D0854, 33F23E0572, 33F23F0594, 33F23G0540, 33F23J0544, 33F23K0174, 33F23L0950, 33F24B0010, 33F24C0060, 33F24D0993, 33F24D1040, 33F24E0268, 33F24E0809, 33F24F0155, 33F24J0037, 33F24M0007, 33F24M0040, 33F24M0165, 33F24M0217, 33F25A0406, 33F25B0269, 33F25C0021, 33F25C0045, 33F25C0642, 33F25D0013, 33F25D0713, 33F25F0249, 33F25H0296, 33F25J0051; CS-15322-VSP/20801902195184/33F23C0869, 33F23D0862, 33F23F0723, 33F23H0985, 33F24A0272, 33F24C0066, 33F24E0813, 33F24G0170, 33F24G0185, 33F24H0256, 33F24J0040, 33F24L0183, 33F24M0222, 33F25A0426, 33F25C0022, 33F25C0593, 33F25E1082, 33F25G0024, 33F25H0297; CS-15362-VSP/30801902195525/33F23C0875, 33F23G0546, 33F23K0195, 33F24E0186, 33F24H0039, 33F24L0201, 33F24M0235, 33F25C0647, 33F25E0326, 33F25G0058, 33F25J0043; CS-15552-VSP/30801902195198/33F23G0552, 33F23H0987, 33F23L0961, 33F24C0070, 33F24E0820, 33F24H0257, 33F24L0068, 33F24M0227, 33F25C0654, 33F25E0432; CSD-15242-SP/20801902096610/33F24A0303, 33F25C0688; CSD-15282-SP/20801902096634/33F23K1087, 33F24A0297; CS-15242-SPM/10801902193527/33F23D0867, 33F23K0192, 33F24A0288, 33F24E0802, 33F24M0244, 33F25C0669, 33F25E0338, 33F25G0586; CS-15282-SPM/10801902193688/33F23C0872, 33F23D0864, 33F23G0539, 33F23L0949, 33F24A0278, 33F24C0075, 33F24E0808, 33F24H0254, 33F24J0036, 33F24L1166, 33F24M0233, 33F25A0413, 33F25C0666, 33F25H0824; CS-15322-SPM/30801902193538/33F23D0865, 33F23H1010, 33F23L0955, 33F24E0812, 33F25C0682, 33F25E0335; CS-15362-SPM/20801902193548/33F24G0062

Distribution pattern

Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW

device · product 4 of 4

NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-15232-SFXM; NextStep Retrograde Hemodialysis Catheter, REF: AC-15192-X, AC-15232-X, AC-15272-X, CS-15192-X, CS-15232-X, CS-15272-X, CS-15312-X; NextStep Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-XM, CS-15232-XM, CS-15272-XM, CS-15312-XM

Z-2159-2026
Recall number
Z-2159-2026
Initiated
April 10, 2026
Classification
Class I
Status
Ongoing
Recalling firm
ARROW INTERNATIONAL, LLC
Quantity
19,687

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

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

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

Code information

REF/UDI-DI/Lots: AC-15192-SFX/30801902197758/AC-15192-SFX; AC-15232-SFX/00801902095909/33F23H1018; CS-15192-SFX/30801902195297/33F23E0575, 33F23G0530, 33F23K0187, 33F23K1104, 33F23L0929, 33F24A0275, 33F24C0068, 33F24D1012, 33F25C0020, 33F25E1083, 33F25G0636, 33F25H0292, 33F25H0790, 33F25L0038; CS-15232-SFX/30801902195549/33F23E0576, 33F23G0534, 33F23L0936, 33F24A0279, 33F24C0067, 33F24D1006, 33F24E0684, 33F24H0258, 33F24J0033, 33F24J0085, 33F24J0342, 33F24L0056, 33F24M0231, 33F25A0405, 33F25C0036, 33F25C0664, 33F25D0739, 33F25E0433, 33F25G0716, 33F25H0248; CS-15272-SFX/10801902195217/33F23B0321, 33F23D0859, 33F23H0500, 33F23K0177, 33F23L0943, 33F24A0280, 33F24C0083, 33F24H0042, 33F24H0260, 33F24J0022, 33F24J0038, 33F24J0088, 33F24L0177, 33F25C0028, 33F25E1090, 33F25F0301, 33F25F0514; CS-15312-SFX/30801902197529/33F23G0541, 33F23H0984, 33F23L0951, 33F24A0283; CS-15422-SFX/30801902195327/33F23K0179, 33F23L0956, 33F24A0290, 33F24E0814; CS-15502-SFX/30801902195563/33F23L0959, 33F24A0286, 33F24J0060; CS-15192-SFXM/10801902127157/33F25C0015, 33F25E1084; CS-15232-SFXM/10801902127232/33F25C0671; AC-15192-X/ 00801902095879/33F23F0744, 33F24E0784, 33F25D0685; AC-15232-X/00801902095916/33F23H1013, 33F24J0068, 33F25C0675, 33F25J0589; AC-15272-X/00801902095954/33F23H1023; CS-15192-X/30801902195303/33F23C0886, 33F23E0564, 33F23G0263, 33F23G0533, 33F23K0712, 33F23L0935, 33F24E0187, 33F24E0793, 33F24G0171, 33F24J0017, 33F24J0041, 33F25D0701, 33F25E0476, 33F25F0486, 33F25H0783, 33F25H0857; CS-15232-X/30801902195556/33F23C0862, 33F23E0566, 33F23F0722, 33F23K0171, 33F23L0940, 33F24A0916, 33F24C0061, 33F24D1037, 33F24E0800, 33F24J0043, 33F24L0176, 33F25A0028, 33F25C0029, 33F25C0644, 33F25D0096, 33F25E0352, 33F25F0300, 33F25F0513, 33F25E0477, 33F25J0745; CS-15272-X/10801902195224/33F23C0887, 33F23F0731, 33F23H0983, 33F23K0190, 33F23L0947, 33F24E0807, 33F24F0124, 33F24J0018, 33F24J0050, 33F24L0054, 33F24L0063, 33F24M0006, 33F25C0684, 33F25E0342, 33F25F0276, 33F25J0641; CS-15312-X/30801902195310/33F23C0863, 33F23D0858, 33F23G0544; CS-15192-XM/10801902127225/33F25D0711; CS-15232-XM/10801902127300/33F25E0435; CS-15272-XM/10801902127409/33F25C0680, 33F25K0272; CS-15312-XM/10801902127508/33F25E0442

Distribution pattern

Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW

Field note

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