FDA Device recall Z-1326-2018

AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A

FDA Device
Class II
terminated
Published 2018-04-18

On 2018-04-18 the FDA classified a Class II recall of AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A by Arrow International, citing certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1326-2018
Classification	Class II
Status	terminated
Initiated	2017-12-22
Published	2018-04-18
Last updated	2026-09-13 11:54 UTC
Company	Arrow International
Distribution	DC

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

Reason

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

Identifiers

code_info	Lot Numbers: (1) 13F17A0135, 13F17C0355, 13F17E0212, 13F17E0789, 13F17F0386; (2) 13F17A0028, 13F17E0044, 13F17E0448; (3… 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,

code_info

Lot Numbers: (1) 13F17A0135, 13F17C0355, 13F17E0212, 13F17E0789, 13F17F0386; (2) 13F17A0028, 13F17E0044, 13F17E0448; (3…

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,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1326-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.