Reported Sep 23, 2015 · Terminated

Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator…

Medivators, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medivators, Inc. · 14605 28th Ave N · Plymouth, MN · 55447-4822

Is this the product you have?

  • 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.
Lot codes and dates
  • Lot 759491A
Amount recalled
840 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 4, 2015 · Data as of Sep 19, 5:33 PM UTC

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