Product Wiki · Recalls · Health Canada — Medical Devices

DiamondTemp Unidirectional Catheter (2021-02-26) — recall 62292

Health Canada — Medical Devices · Canada · 2021-04-01 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
62292
Date of alert
2021-04-01
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: This notification is to provide customers with important information regarding an error in the Instructions For Use (IFU) and package label for Diamondtemp Catheters relating to size and sheath compatibility. This notification provides corrections that address the potential risks associated with incorrect sheath size selection. Potential risks associated with sheath exchange, or use of inadequate sheath size, include blood stagnation, clots or air emboli.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/diamondtemp-unidirectional-cat

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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