Z-2761-2015 Class II Terminated
FDA device recall Z-2761-2015 was initiated by Medivators, Inc. on August 3, 2015 and is designated Class II. Reason for recall: Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification. The recall status is terminated (terminated November 4, 2015). Affected quantity: 840 units.
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