FDA Recalls QUADROX-i Small Oxygenator Due to Packaging Integrity Issues
Maquet Medical Systems USA is recalling 1,784 QUADROX-i Small Oxygenators due to packaging defects that may compromise the sterile barrier, risking infection and other serious complications.
- Product
- BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905
- Category
- Medical Device
- Distribution
- Distributed nationwide