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U.S. Department of Health and Human Services

Class 2 Device Recall Centrifugal Pumphead with XCoating

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 Class 2 Device Recall Centrifugal Pumphead with XCoatingsee related information
Date Initiated by FirmApril 14, 2014
Date PostedJuly 11, 2014
Recall Status1 Terminated 3 on September 07, 2016
Recall NumberZ-2029-2014
Recall Event ID 68024
510(K)NumberK112229 
Product Classification Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
ProductSarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Code Information Lot No. RC07, QM03, QN07, and RA09.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd
Elkton MD 21921-5315
For Additional Information ContactGarry A. Courtney
410-392-7102
Manufacturer Reason
for Recall		During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
FDA Determined
Cause 2		Device Design
ActionUrgent Medical Device Recall letters, dated April 11, 2014, were sent to customers. The letters identified the affected product, as well as the reason for the correction, the potential hazard, the correction, the affected population, and instructions for customers. Customers are to review the notice and ensure that all users have received a copy. Additionally, customers are to confirm receipt of the communication by returning the attached Customer Response Form as instructed; and, return all effected centrifugal pumps. Terumo CVS will issue a Returned Goods Authorization upon receipt of the Response Form. Questions should be directed to Terumo CVS Customer Service at 800-521-2818.
DistributionNationwide Distribution
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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