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Terminated

Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A

FDA Recall Z-1328-2018 · Posted None

Recall StatusTerminated
Product CodeNIE
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.

Official Source

View FDA Recall →

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

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