Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-contro

FDA device recall Z-1569-2013 · posted 2013-06-21 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

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.

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

Root cause

Employee error

Status

Terminated

Product code

DWC

Quantity affected

7 units

Distribution

Worldwide Distribution including the countries of UAE (United Arab Emirates) HONG KONG and THAILAND. Not distributed in USA

Date initiated

2013-05-30

Date posted

2013-06-21

Date terminated

2013-09-17

Location

Ann Arbor, MI

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