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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 Systemsee related information
Date Initiated by FirmSeptember 24, 2012
Date PostedOctober 11, 2012
Recall Status1 Terminated 3 on November 13, 2013
Recall NumberZ-0052-2013
Recall Event ID 62059
510(K)NumberK882758 
Product Classification Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
ProductSarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Code Information Catalog number: 6380 and serial numbers: 5007, 5028-5030, 5032, 5075, 5076, 5135,6010,6013,6025,6030,6116, 7000-7197,7372, and 7373.
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
ActionTERUMO 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 Commerce213 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = KFM
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