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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific

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  Class 2 Device Recall Boston Scientific see related information
Date Initiated by Firm October 25, 2005
Date Posted December 01, 2005
Recall Status1 Terminated 3 on June 20, 2007
Recall Number Z-0257-06
Recall Event ID 33993
Product Classification Retractor - Product Code GAD
Product TLC Self -Retaining Retractor System-Single

Product Code: 820-175
Code Information All lot codes
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information Contact Robert T. Miragliuolo
508-683-4186
Manufacturer Reason
for Recall		 Sterility of device compromised due to breach in packaging
FDA Determined
Cause 2		 Other
Action Boston Scientific initiated the recall on October 25, 2005 to accouunts requesting the return of the product and completion of the Reply Verification Tracking Form.
Quantity in Commerce 5185
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.
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