Affinity Fusion Oxygenators

Affinity Fusion Oxygenators Recall Affinity Fusion Oxygenators are being recalled across Canada due to performance issues. These medical devices are used during heart surgery to oxygenate blood. The recall is classified as Class I, which indicates a serious potential health concern.

Product
Affinity Fusion Oxygenators
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2023-01-04
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/86405177-318c-4e8b-97e0-e68cecc76207