Recall Z-1569-2013
Terumo Cardiovascular Systems Corporation · initiated May 30, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Catalog Number 4416 and Serial Numbers: 4656, 4657, 4658,4659, 4661, 4662, and 4663.
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.
FDA-determined cause: Employee error
Action taken
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
Details
- Recall number
- Z-1569-2013
- Initiated
- May 30, 2013
- Posted by FDA
- June 21, 2013
- Terminated
- September 17, 2013
- Product code
- DWC – Controller, Temperature, Cardiopulmonary Bypass
- Quantity
- 7 units
- Distribution
- Worldwide Distribution including the countries of UAE (United Arab Emirates) HONG KONG and THAILAND. Not distributed in USA
- Recalling firm
- Terumo Cardiovascular Systems Corporation, Ann Arbor, MI