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.
Reported: September 23, 2015 Initiated: August 3, 2015 #Z-2761-2015
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.
Details
- Recalling Firm
- Medivators, Inc.
- Units Affected
- 840 units
- Distribution
- US Distribution to the states of CA and MI.
- Location
- Plymouth, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medivators, Inc.. Units affected: 840 units.
Why was this product recalled? ▼
Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 23, 2015. Severity: Moderate. Recall number: Z-2761-2015.
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