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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