Health product recall

Aquacel Ag Foam Dressing, Adhesive

Brand(s)
Last updated

Summary

Product
Aquacel Ag Foam Dressing, Adhesive
Issue
Medical devices - Performance issue
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: 2023-02-07
Alert / recall type
Health product recall
Category
Health product - Medical device - 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