Reported Jul 22, 2015 · Terminated
Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6…
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?
- Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
- Lot codes and dates
- Product code 16-02-81 Serial number 16S10743-16S11708
- Amount recalled
- 21
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
Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
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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