Z-2761-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2015
- Initiation Date
- August 3, 2015
- Termination Date
- November 4, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 840 units
Product Description
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.
Reason for Recall
Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.
Distribution Pattern
US Distribution to the states of CA and MI.
Code Information
Lot 759491A