Reported Jul 3, 2013 · Terminated
Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of…
Terumo Cardiovascular Systems Corporation
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: Terumo Cardiovascular Systems Corporation · 6200 Jackson Road · Ann Arbor, MI · 48103-9586
Is this the product you have?
- Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature
- Lot codes and dates
- Catalog Number 4416 and Serial Numbers
465646574658465946614662and 4663
- Catalog Number 4416 and Serial Numbers
- Amount recalled
- 7 units
Why it was recalled
Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.
This product could cause temporary or reversible health problems — stop using it.
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