Revaclear 400 Dialyzer; Revaclear 300 Dialyzer

Revaclear 400 and 300 Dialyzers are being recalled across Canada due to a performance issue. Dialyzers are medical devices used during kidney dialysis treatment. The FDA classified this as a Class I recall, which is the most serious type.

Product
Revaclear 400 Dialyzer; Revaclear 300 Dialyzer
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2022-12-02
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/28ab1a59-3624-4497-a484-67e8cea4b501