Device product
Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
Z-1373-2016
Product summary
- Event
- Event 73390
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72,000 units in total
- Official record key
device-enforcement:Z-1373-2016
Official wording
Reason: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
Code information: BEQ-RF32, BEQ-RF-32-USA, BO-RF-32, BO-RF-32 USA, RF-32, RF-32 USA, RF-32u.
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.