Product Wiki · Recalls · Health Canada — Medical Devices

DISPOSABLE BIPOLAR ABLATOR, ASPIRATING & NON-ASPIRATING (2021-02-01) — recall 62227

Health Canada — Medical Devices · Canada · 2021-03-11 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
62227
Date of alert
2021-03-11
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Package integrity failure leading to potential breach of the sterile barrier and potential contamination of the sterile product inside packaging. There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration. Issue was discovered after worst case transportation / handling / shipping/extreme temperature conditions showed package integrity failure in 10.5% of samples tested.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/disposable-bipolar-ablator-asp

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