Affinity Fusion Oxygenator adapter may loosen during cardiac surgery
Medtronic is recalling Affinity Fusion Oxygenators because the Temperature Monitoring Adapter may come loose during setup or disassembly of the heart-lung machine used in cardiac surgery. No injuries have been reported.
- Product
- Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
- Category
- Medical Device
- Distribution
- Distributed nationwide