Health product recall

Umbilical Vessel Catheters

Last updated

Summary

Product
Umbilical Vessel Catheters
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Argyle Polyurethane Umbilical Vessel Catheter Triple Lumen 2335500149 8888160648
Argyle Polyurethane Umbilical Vessel Catheter Single Lumen More than 10 numbers, contact manufacturer. 8888160325 8888160333 8888160341
Argyle Polyurethane Umbilical Vessel Catheter Dual Lumen 2424900135 2424900134 2424900133 2435200124 8888160556

Issue

Cardinal Health has initiated a medical device product recall on specific product codes and lots of Umbilical Vessel Catheters. The list of affected product codes and lots are being recalled due to a possible packaging defect impacting the outer tyvek pouch that protects the sterile product. This pouch is used on both the Single-Sterile Umbilical Vessel Catheters and the product within a finished insertion tray. This defect may allow for small holes to develop in the pouch which could potentially compromise the sterility of the product. These holes may be undetectable upon visual inspection, so none of the identified lots should be used.

Recall Start Date: May 5, 2025

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Cardinal Health 200, Llc Also Trading As Cardinal Health

3651 Birchwood Drive, Waukegan, Illinois, United States, 60085

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77456

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