Aquacel Ag Foam Dressing, Adhesive
Brand(s)
Last updated
Summary
Product
Aquacel Ag Foam Dressing, Adhesive
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Aquacel Ag Foam Dressing, Adhesive | 2C03689 | 420681 |
Issue
Convatec is conducting a medical device recall for a specific lot of Aquacel® Ag foam adhesive 10cm x 10cm due to the visual contamination in the form of brown spots present on dressings.
An internal investigation determined that the likely root cause is due to contamination of oil or grease being transferred during production, from tooling equipment onto the product.
For this reason and to address any potential risk of harm, all of the affected products should not be used.
Recall start date: January 17, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
Convatec Inc.
7815 National Service Road, Greensboro, North Carolina, United States, 27409
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72659
Get notified
Receive notifications for new and updated recalls and alerts by category.