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U.S. Department of Health and Human Services

Class 3 Device Recall MediTech Stainless Steel Greenfield Vena Cava Filter

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  Class 3 Device Recall MediTech Stainless Steel Greenfield Vena Cava Filter see related information
Date Initiated by Firm October 06, 2006
Date Posted May 10, 2007
Recall Status1 Terminated 3 on July 03, 2012
Recall Number Z-0794-2007
Recall Event ID 37837
510(K)Number K964284  
Product Classification Vena Cava Filter - Product Code DTK
Product Boston Scientific Medi-Tech Stainless Steel Greenfield Vena Cava Filter, order #50-400, lot #7826572
Code Information Lot #7826572
Recalling Firm/
Manufacturer		 Boston Scientific
1 Scimed Pl
Maple Grove MN 55311-1565
Manufacturer Reason
for Recall		 One lot of product, Stainless Steel Greenfield Vena Cava Filter, may have the incorrect expiration date of 2008-07 and the correct date is 2008-06.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter (10/06/2006) which was accompanied by a Reply Verification Letter. All consignees were asked to cease use of product upon receipt of the letter and to fax the Reply Verification Letter to recalling firm and return product to firm.
Quantity in Commerce 24 units
Distribution Nationwide.
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 = DTK and Original Applicant = BOSTON SCIENTIFIC CORP.
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