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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns " TCM II Temperature Control Module

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 Class 2 Recall
Sarns " TCM II Temperature Control Module
see related information
Date Posted June 21, 2013
Recall Status1 Terminated on September 17, 2013
Recall Number Z-1569-2013
Recall Event ID 64530
Premarket Notification
510(K) Number
K883603 
Product Classification Controller, Temperature, Cardiopulmonary Bypass - Product Code DWC
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
Code Information Catalog Number 4416 and Serial Numbers: 4656, 4657, 4658,4659, 4661, 4662, and 4663.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mary Swift
800-262-3304 Ext. 6056
Manufacturer 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 2
TRAINING: 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 in Commerce 7 units
Distribution Worldwide Distribution including the countries of UAE (United Arab Emirates) HONG KONG and THAILAND. Not distributed in USA
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWC and Original Applicant = 3M HEALTH CARE, SARNS
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