AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-4...
FDA Recall #Z-1326-2018 — Class II — December 22, 2017
Product Description
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
Reason for Recall
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Recalling Firm
Arrow International Inc — Reading, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Distribution
Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated