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No image published for this recall

Aquacel ag foam dressing, adhesive

Official notice

7 Feb 2023

Last checked

7 Feb 2023

Medium riskHealth Canada

An official Health Canada notice concerns Aquacel ag foam dressing, adhesive. 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 Published 2023-02-07.

What to do now

Contact the manufacturer if you require additional information.

Recall number

72659

Official notice

2023-02-07

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

72659

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Affected products

Product 1

Affected products - Aquacel Ag Foam Dressing, Adhesive, Lot or serial number - 2C03689, Model or catalogue number - 420681

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Convatec, Aquacel Foam Dressing Adhesive.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

72659

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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