Product Wiki · Recalls · Health Canada — Medical Devices

Revaclear 400 Dialyzer; Revaclear 300 Dialyzer — recall 72234

Health Canada — Medical Devices · Canada · 2022-12-02 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
72234
Date of alert
2022-12-02
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Anaesthesiology
Product type
Medical devices
Reported risk: Baxter Corporation is communicating two separate, but associated, issues related to Revaclear dialyzers. The first issue is linked to reports of internal blood leaks being caused by a twisted gasket in the dialyzer, prompting Baxter to recall the impacted lots. The second issue is linked to reports of polyurethane displacement in the dialyzer, prompting Baxter to issue a safety alert for the impacted lots. Recall start date: November 24, 2022
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/revaclear-400-dialyzer-revacle

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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