Z-1326-2018 Class II Terminated
FDA device recall Z-1326-2018 was initiated by Arrow International Inc on December 22, 2017 and is designated Class II. Reason for recall: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. The recall status is terminated (terminated May 27, 2020).
Recall Details
- Product Type
- Devices
- Report Date
- April 18, 2018
- Initiation Date
- December 22, 2017
- Termination Date
- May 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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.
Distribution Pattern
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