FDA Enforcement
Class II
Terminated
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.
Recall: Z-2761-2015
·
Reported September 23, 2015
Enforcement
- Recall Number
- Z-2761-2015
- Event ID
- 72122
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medivators, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 23, 2015
- Initiation Date
- August 3, 2015
- Classification Date
- September 11, 2015
- Termination Date
- November 4, 2015
- Address
- 14605 28th Ave N, Plymouth, MN, 55447-4822, United States
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
Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.
Code Info
Lot 759491A
Distribution
US Distribution to the states of CA and MI.
Quantity
840 units