Public recall detail

Aquacel Ag Foam Dressing, Adhesive

2023-02-07

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Recall Safety notice
Quick summary

Quick summary: Aquacel Ag Foam Dressing, Adhesive. Date: 2023-02-07.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Aquacel Ag Foam Dressing, Adhesive. Date: 2023-02-07.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandCONVATEC INC.
ProductAquacel Ag Foam Dressing, Adhesive
IssueMedical devices - Performance
Recall classType II
IdentificationRA-72659

Affected products

ProductAquacel Ag Foam Dressing, Adhesive
Lot2C03689
Model420681
Serial number2C03689
DescriptionAquacel Ag Foam Dressing, Adhesive

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General and plastic surgery
CompaniesConvatec Inc. 7815 National Service Road, Greensboro, North Carolina, United States, 27409
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-72659
Background{}
CompaniesConvatec Inc. 7815 National Service Road, Greensboro, North Carolina, United States, 27409
AudiencesHealthcare
Source updated2023-02-07

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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