Device product
Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.
Z-1461-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79713
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,267
- Official record key
device-enforcement:Z-1461-2018
Official wording
Reason: Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.
Code information: All lots
Distribution pattern: Worldwide Distribution -- USA, Argentina, Bolivia, Brazil, Canada, Colombia, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela.
Derived failure modes
-
Unknown
Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.