Recall Z-1569-2013 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
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
| Date | Jun 21, 2013 (initiated May 30, 2013) |
| Status | Terminated |
| Reason | Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail. |
| Root cause | Employee error |
| Action | 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 |
| Quantity | 7 units |
| Distribution | Worldwide Distribution including the countries of UAE (United Arab Emirates) HONG KONG and THAILAND. Not distributed in USA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883603 | SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) 3M Health Care, Sarns, Nov 3, 1988 |