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Medivators, Inc. recalls Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator
Recalled September 23, 2015 · FDA recall Z-2761-2015 · Medivators
Hazard
Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification. · FDA Class II
Units
840 units
Sold at
US Distribution to the states of CA and MI.
Description
Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.
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.
Manufacturer(s)
Medivators, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →