Device product
Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed.
Z-2761-2015
Product summary
- Firm
- Medivators, Inc.
- Event
- Event 72122
- Status
- Terminated
- Classification
- Class II
- Quantity
- 840 units
- Official record key
device-enforcement:Z-2761-2015
Official wording
Reason: Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.
Code information: Lot 759491A
Distribution pattern: US Distribution to the states of CA and MI.
Derived failure modes
-
Unknown
Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.