Medivators, Inc. recalls Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator i…

Recall date

August 3, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2761-2015

FDA classification

Class II

Brand / firm

Medivators, Inc.

Sold / distributed

US Distribution to the states of CA and MI.

Why it was recalled

Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.