FDAFDA · Food and drugs·Recall number Z-1569-2013
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
Published July 3, 2013 · Recall initiated: May 30, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Distributor
- Worldwide Distribution including the countries of UAE (United Arab Emirates) HONG KONG and THAILAND. Not distributed in USA
- Lot
- Catalog Number 4416 and Serial Numbers: 4656, 4657, 4658,4659, 4661, 4662, and 4663.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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