Device product

AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3) AK-45703-PB1A; AGB+ Pressure Injectable Multi-Lumen CVC Kit (4) CA-42703-P1A; (5) CA-42854-P1A; (6) CA-45703-P1A; AGB+ Pressure Injectable Quad-Lumen CVC Kit (7) CA-45854-P1A; (8) CDA-42703-P1A; AGB+ Quad-Lumen CVC Kit (9) AK-42854-P1A; (10) AK-45854-P1A; AGB+ Two Lumen CVC Kit (11) AK-42802-P1A; (12) AK-45802-P1A; (13) AK-46702-P1A; (14) AK-47702-P1A; ARROWg+ard BLUE PLUS Pressure Injectable Multi-Lumen CVC Kit (15) CDA-45703-P1A; ARROWg+ard BLUE PLUS Pressure Injectable Quad-Lumen CVC Kit (16) CDA-45854-P1A; ARROWg+ard BLUE PLUS Pressure Injectable Two-Lumen CVC Kit (17) CDA-22122-U1A; (18) CDA-42802-P1A; (19) CDA-42854-P1A; (20) CDA-47702-P1A; ARROWg+ard Blue¿ MAC" Two-Lumen CVC Access Kit (21) CDA-21242-1A; ARROWg+ard Blue¿ PSI Kit (22) CDA-29803-1A; ARROWg+ard Blue¿ Two-Lumen CVC Kit (23) AK-22702-P1A; ARROWg+ard Blue¿ You-Bend" Two- Lumen Hemodialysis Catheterization Kit for High Volume Infusions (24) CDA-25122-U1A; Multi-Lumen CVC Kit with Blue FlexTip(R) Catheter and Sharps Safety Features (25) ASK-12703-PRJ; (26) ASK-15703-PRJ; Multi-Lumen Pressure Injectable Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features (27) ASK-45703-PRH; Pressure Injectable ARROWg+ard Blue Plus(R) Multi-Lumen CVC Kit (28) ASK-45703-PRWJ1; Pressure Injectable ARROWg+ard Blue PLUS(R) Quad-Lumen CVC Kit (29) ASK-42854-PRJ; Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central CVC Kit (30) ASK-47702-PPHP; Pressure Injectable ARROWg+ard Blue PLUS(R)Multi-Lumen CVC Kit (31) ASK-45703-PUCD; Pressure Injectable Multi-Lumen CVC Kit (32) ASK-12703-PCA; (33) ASK-15703-PCA; (34) ASK-15703-PHH; (35) ASK-15703-PLV; Pressure Injectable Multi-Lumen CVC kit with Blue Flex Tip¿, ARROWg+ard Blue PLUS¿ Catheter and Sharps Safety Features (36) ASK-42703-PBM; (37) ASK-15703-PRH; (38) ASK-15703-PRWJ; (39) ASK-42703-PRJ; (40) ASK-45703-PRJ; Pressure Injectable Quad-Lumen CVC Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions (41) ASK-42854-PNMM; Pressure Injectable Two Lumen CVC Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features (42) ASK-42802-PBM

Z-1326-2018

December 22, 2017

Class II

Product summary

Firm: Arrow International Inc
Event: Event 79512
Status: Terminated
Classification: Class II
Quantity: Unavailable
Official record key: device-enforcement:Z-1326-2018

Official wording

Reason: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information: Lot Numbers: (1) 13F17A0135, 13F17C0355, 13F17E0212, 13F17E0789, 13F17F0386; (2) 13F17A0028, 13F17E0044, 13F17E0448; (3) 13F17B0118, 13F17F0385; (4) 13F17B0152, 13F17C0057; (5) 13F17F0226; (6) 13F17A0157, 13F17B0117, 13F17C0250; (7) 13F17F0071; (8) 13F17A0022, 13F17A0301, 13F17C0266, 13F17D0039; (9) 13F17B0041, 13F17E0764; (10) 13F16M0169, 13F17B0262, 13F17C0468; (11) 13F17D0323, 13F17E0310, 13F17E0467; (12) 13F17B0085, 13F17E0150, 13F17F0345; (13) 13F17E0751; (14) 13F17E0211; (15) 13F17A0167, 13F17B0145, 13F17C0466, 13F17E0095, 13F17F0261; (16) 13F17C0325, 13F17D0283; (17) 13F17E0616, 13F17F0256; (18) 13F17C0318; (19) 13F16M0048, 13F17E0124,13F17F0497; (20) 13F17B0249; (21) 13F17F0437; (22) 13F17C0267, 13F17E0385; (23)13F17D0194, 13F17F0486; (24) 13F16M0184, 13F17E0617; (25) 13F17B0279, 13F17D0112; (26) 13F17B0265; (27) 13F17E0402; (28) 13F17A0067; (29) 13F17E0796; (30) 13F17C0492; (31) 13F17C0140, 13F17D0055, 13F17F0255; (32) 13F17F0240; (33) 13F17F0575; (34) 13F17B0239, 13F17C0300, 13F17D0297, 13F17F0015; (35) 13F17E0390; (36) 13F17B0134, 13F17C0472; (37) 13F17C0279; (38) 13F17B0199, 13F17C0400; (39) 13F17A0296, 13F17D0110, 13F17F0319; (40) 13F16M0019, 13F17B0343, 13F17D0113; (41) 13F17A0172, 13F17B0401, 13F17E0163, 13F17E0631, 13F17F0338; (42) 13F17E0543, 13F17F0208

Distribution pattern: Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.