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
Reported: July 3, 2013 Initiated: May 30, 2013 #Z-1569-2013
Product Description
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
Reason for Recall
Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.
Details
- Recalling Firm
- Terumo Cardiovascular Systems Corporation
- Units Affected
- 7 units
- Distribution
- Worldwide Distribution including the countries of UAE (United Arab Emirates) HONG KONG and THAILAND. Not distributed in USA
- Location
- Ann Arbor, MI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 7 units.
Why was this product recalled? ▼
Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 3, 2013. Severity: Moderate. Recall number: Z-1569-2013.
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