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U.S. Department of Health and Human Services

Class 2 Device Recall Centrifugal Pumphead, Cardiovascular Procedure Kit with Centrifugal Pump

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  Class 2 Device Recall Centrifugal Pumphead, Cardiovascular Procedure Kit with Centrifugal Pump see related information
Date Initiated by Firm May 27, 2015
Date Posted February 22, 2017
Recall Status1 Terminated 3 on February 23, 2017
Recall Number Z-1235-2017
Recall Event ID 76386
510(K)Number K112229  
Product Classification Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
Product The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.
Code Information TAOS, TC03
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd
Elkton MD 21921-5315
Manufacturer Reason
for Recall		 Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected during priming of the bypass circuit and during CPB procedures. In each of the reported incidents, there were no reports of patient injury as a result of the centrifugal pump leaks. Terumo Cardiovascular System's investigation into the incident has identified the cause of the leaks to be cracks in both the Top Housing and Magnet Back Housing of the pump. When the cracks cause the housing to become compromised, it is possible for fluid to leak from the pump head.
FDA Determined
Cause 2		 Process control
Action Customer Notification Letter/Response Form is being sent to all affected consignees.
Quantity in Commerce 579 units have entered into the distribution chain
Distribution Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall
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 = TERUMO CARDIOVASCULAR SYSTEMS
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