FDA-Device2015-09-23Class II
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.
Medivators, Inc.
Hazard
Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.
Sold states
US Distribution to the states of CA and MI.
Affected count
840 units
Manufactured in
14605 28th Ave N, Plymouth, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2761-2015Don't want to check this manually?
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