Recall MonitorHealth Products
Umbilical Vessel Catheters
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: Umbilical Vessel Catheters
Issue: Medical devices - Labelling and packaging
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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