Health Canada — Medical Devices · Canada · 2022-12-15 · Type II
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Reported risk: The pump that circulates the water from the Criticool® device into the Curewrap® may experience premature failure due to loose hardware on the pump component. This premature failure leads to the Criticool® device displaying a halt 4 error, from which the device cannot recover even after a device reboot. Recall start date: November 15, 2022
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.
ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.