Reported Aug 2, 2017 · Terminated
STOCKERT Heater-Cooler System 3T, 208V/60 Hz
Sorin Group USA, 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: Sorin Group USA, Inc. · 14401 W 65th Way · Arvada, CO · 80004-3503
Is this the product you have?
STOCKERT Heater-Cooler System 3T208V/60 Hz
- Lot codes and dates
Item No. 16-02-82Serial No. 16S10772-16S16840
- Amount recalled
- 7,546 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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