| Class 2 Device Recall Terumo Weighted Flexible Sucker |  |
Date Initiated by Firm | February 05, 2008 |
Date Posted | August 04, 2009 |
Recall Status1 |
Terminated 3 on November 01, 2009 |
Recall Number | Z-2046-2009 |
Recall Event ID |
46722 |
510(K)Number | K982891 |
Product Classification |
Cardiopulmonary Bypass Cardiotomy Return Sucker - Product Code DTS
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Product | Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113. |
Code Information |
Lots 0394979, 0400254, 0403180, 0405486, 0411500, 0414942, 0420022, 0424246, 0427742, 0430190, 0435074, 0436862, 0443077, 0452056, 0465817, 0470928, 0479748, 0484668 and 0491029. |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor MI 48103-9586
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For Additional Information Contact | 734-741-6173 |
Manufacturer Reason for Recall | A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient. |
FDA Determined Cause 2 | Process control |
Action | Consignees were notified via Urgent - Medical Device Removal letters dated 2/5/08 to cease use of the product. Terumo CVS will contact customers to arrange replacement for the affected product upon receipt of the attached response form. Questions are to be directed to Terumo CVS Customer Service at 1-800-521-2818. |
Quantity in Commerce | 7079 |
Distribution | Worldwide Distribution --- including USA and countries of Belgium, Brazil, Dominican Republic, Germany, Jordan and Latin America. |
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 = DTS
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