Quadrox-i Pediatric Oxygenator With Integrated Hardshell Reservoir (2020-12-21)
Recall Summary Quadrox-I Pediatric Oxygenators with integrated hardshell reservoirs are being recalled across Canada. The recall was issued due to a defect identified in these medical devices used in pediatric cardiac procedures. This recall affects all units of this device that were distributed in Canada.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2020-12-31
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/147abd07-3bdd-440f-9c1d-a2f1e9cd9db9