Date Initiated by Firm | October 25, 2005 |
Date Posted | December 01, 2005 |
Recall Status1 |
Terminated 3 on June 20, 2007 |
Recall Number | Z-0259-06 |
Recall Event ID |
33993 |
Product Classification |
Retractor - Product Code GAD
|
Product | TLC Retractor and Single Step Pelvic Drape (contains 1 Product Code 820-175)
Product Code: 820-177 |
Code Information |
All lots |
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 | 310 |
Distribution | Nationwide |
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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