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

Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.

Terumo sent beginning May 30, 2013, an URGENT MEDICAL DEVICE RECALL NOTIFICATION were sent to all customers with instructions to notify all customers of the recall requesting all affected units to be quarantined until the heatsink units are replaced Confirm receipt by filling out the response form containing communication by faxing or emailing the attached Affiliate Response Form to the fax number or email address indicated on the form. Questions should be directed to Terumo CVS customer service in the U.S.: Telephone: +1-734-663-4145; Fax: +1-734-741-6149