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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Weighted Flexible Sucker

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 Class 2 Device Recall Terumo Weighted Flexible Suckersee related information
Date Initiated by FirmFebruary 05, 2008
Date PostedAugust 04, 2009
Recall Status1 Terminated 3 on November 01, 2009
Recall NumberZ-2046-2009
Recall Event ID 46722
510(K)NumberK982891 
Product Classification Cardiopulmonary Bypass Cardiotomy Return Sucker - Product Code DTS
ProductTerumo 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
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
ActionConsignees 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 Commerce7079
DistributionWorldwide Distribution --- including USA and countries of Belgium, Brazil, Dominican Republic, Germany, Jordan and Latin America.
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 = DTS
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