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Coloplast Biatain STD Alginate 10x10cm — recall 76828

Health Canada — Medical Devices · Canada · 2025-01-14 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 76828
Date of alert: 2025-01-14
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: General and plastic surgery
Product type: Medical devices

Reported risk: On 25th July AMS staff identified a defect on primary packaging pouches, during packaging, of minor missing patches of polyethylene. The defect could compromise the device's ability to maintain a sterile barrier. In addition, patches of burnt or cracked polyethylene have been identified on the inside face of the primary. AMS is the contract manufacturer for the Coloplast branded labels. Recall start date: October 14, 2024

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/coloplast-biatain-std-alginate

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Coloplast Biatain STD Alginate 10x10cm — recall 76828

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