| Class 2 Device Recall Sarns Disposable Centrifugal Pump | |
Date Initiated by Firm | April 14, 2014 |
Date Posted | July 11, 2014 |
Recall Status1 |
Terminated 3 on September 07, 2016 |
Recall Number | Z-2028-2014 |
Recall Event ID |
68024 |
510(K)Number | K112229 |
Product Classification |
Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
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Product | Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device.
For use in cardiopulmonary bypass procedures. |
Code Information |
Lot No. RA07, Lot No. QP02 |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 125 Blue Ball Rd Elkton MD 21921-5315
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For Additional Information Contact | Garry 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 |
Action | Urgent 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. |
Distribution | Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = KFM
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