Terminated

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

FDA Recall Z-1326-2018 · Posted None

Recall StatusTerminated

Product CodeFOZ

Date Initiated2017-12-22

Date Terminated2020-05-27

Reason for Recall

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

Firm Action

The notification letter includes the following instructions for CUSTOMERS: 1. Discontinue use and quarantine any affected products. 2. Complete and return the Recall Acknowledgement Form to start return process. 3. Complete the Recall Acknowledgment Form if there is no product on hand. Instructions for DISTRIBUTORS: 1.Discontinue distribution and quarantine any affected products. 2. Communicate this recall to any customers with affected product. 3. Have the customers return any affected product to you with a completed Recall Acknowledgement Form. 4. Return affected products from inventory using the Recall Acknowledgement Form. 5. Once you have returned recalled products from your own inventory, and collected the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and return the form.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071538ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETERArrow International, Inc. · 2007-08-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.