Back to RecallTracker
Health Canada Medical devices

Revaclear 400 Dialyzer; Revaclear 300 Dialyzer

Issued December 2, 2022
Issue
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
Hazard description
Performance
Product
Product name
Revaclear 400 Dialyzer; Revaclear 300 Dialyzer
Reference
ID
RA-72234