Health Canada — Medical Devices · Canada · 2023-02-07 · Type II
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Reported risk: 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
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