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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns Centrifugal System

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  Class 2 Device Recall Sarns Centrifugal System see related information
Date Initiated by Firm September 24, 2012
Date Posted October 11, 2012
Recall Status1 Terminated 3 on November 13, 2013
Recall Number Z-0051-2013
Recall Event ID 62059
510(K)Number K882758  
Product Classification Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
Product Sarns Centrifugal System Control module, 100/115V

The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Code Information Catalog number: 6379 and serial numbers: 942,1003-1006,1034,1039,1051,1056,1087,1914,3030,4019,4344, 5009,5012,5013,5030,5048,5059, 5062, 5080, 5096, 5111, 5112, 5122, 5140, 5713, 6003, 6005, 6023, 6024, 6027, 6033, 6034, 6054, 6055, 6060, 6066, 6068, 6069, 6073, 6079, 6081, 6082, 6086, 6089, 6090-6092, 6097, 6107, 6109, 6112, 6119, 6126-6128, 6236, 6379, 7000-7785, and R7051.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
734-741-6173
Manufacturer Reason
for Recall		 Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.
FDA Determined
Cause 2		 Component design/selection
Action TERUMO sent an Urgent Medical Device Recall dated April 13, 2012, to all affected consignees. An Addendum was sent on September 25, 2012. All US Consignees will receive a Safety Advisory and an update to the Operator's Manual via Federal Express to inform them of the reported malfunction and potential hazards and to raise awareness of the benefits of using a retrograde valve and the importance of back-up system availability. TERUMO will include a customer response form and follow up with all affected users to obtain a response to the recall. For questions customers should call 1-800-521-2818. For questions regarding this recall call 734-741-6173.
Quantity in Commerce 847 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Bangladesh, Seoul Korea, Chile, Brazil, Venesuela, Thailand, Mexico, India, Taiwan, Canada, Dominican Republic, Guatemala, Ecuador, Germany, Republic of Georgia, Hong Kong, Japan, United Arab Emirates (UAE), Japan, Belgium, Phillipines, Singapore, and South Africa.
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 = KFM and Original Applicant = 3M HEALTH CARE, SARNS
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