FDA Recall Terminated

(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CDC-17702-1A

Recall: Z-1332-2018 · Initiated December 22, 2017

Recall

Recall Number: Z-1332-2018
Event Number: 79512
Firm: Arrow International Inc
FEI Number: 3015859709
Product Code: DQY
Status: Terminated
Root Cause: Process control
Initiated: December 22, 2017
Terminated: May 27, 2020
Address: 2400 Bernville Rd, Reading, PA, 19605-9607

Description

Reason

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

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.

Distribution

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