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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 Device Recall Sarns " TCM II Temperature Control Module see related information
Date Initiated by Firm May 30, 2013
Date Posted June 21, 2013
Recall Status1 Terminated 3 on September 17, 2013
Recall Number Z-1569-2013
Recall Event ID 64530
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 MI 48103-9586
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWC and Original Applicant = 3M HEALTH CARE, SARNS
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