Reported Apr 17, 2019 · Terminated
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or…
LivaNova 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: LivaNova USA Inc. · 14401 W 65th Way · Arvada, CO · 80004-3503
Is this the product you have?
- SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
- Lot codes and dates
Serial numbers 16S1318716S1488716S1533516S1533616S15337and 16S11877
- Amount recalled
- 6 devices
Where it was sold
Why it was recalled
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
This product could cause temporary or reversible health problems — stop using it.
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