Product Wiki · Recalls · Health Canada — Medical Devices

Leica Cryostats (2019-03-18) — recall 59490

Health Canada — Medical Devices · Canada · 2019-04-12 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
59490
Date of alert
2019-04-12
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: During post market surveillance, it was realized that some customers are using flammable freezing sprays within the Cryostat chamber. Such flammable freezing sprays can potentially ignite and can cause serious injuries. The current device labeling does not include any specific warning about the usage of flammable freezing sprays, therefore the corrective action will improve the device labeling with an adhesive warning label and safety amendment to the instrument instruction for use (IFU).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/leica-cryostats-2019-03-18

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