Recall MonitorHealth Products
Coloplast Biatain STD Alginate 10x10cm
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: Coloplast Biatain STD Alginate 10x10cm
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: Industry
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Coloplast Biatain Std Alginate 10x10cm | W000070556 W00069434 W000068269 W00068634 | 3710 3715 |
Issue
On 25th July AMS staff identified a defect on primary packaging pouches, during packaging, of minor missing patches of polyethylene. The defect could compromise the device's ability to maintain a sterile barrier. In addition, patches of burnt or cracked polyethylene have been identified on the inside face of the primary. AMS is the contract manufacturer for the Coloplast branded labels. Recall start date: October 14, 2024