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Class 2 Device Recall Boston Scientific |
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Date Initiated by Firm |
August 28, 2007 |
Date Posted |
October 31, 2007 |
Recall Status1 |
Terminated 3 on July 10, 2008 |
Recall Number |
Z-0118-2008 |
Recall Event ID |
44736 |
Product Classification |
Biopsy Forceps - Product Code FFF
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Product |
Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 40 UPN Number: M00513332 REF: 1333-40 |
Code Information |
Lot Numbers: 8984687, 8984688, 8984689, 8990186, 9003394, 9003396, 9005718, 9005719, 9017283 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 100 Boston Scientific Way Marlborough MA 01752-1234
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For Additional Information Contact |
508-650-8798
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Manufacturer Reason for Recall |
Device lacked manufacturing finishing process resulting in endoscope damage.
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FDA Determined Cause 2 |
Process control |
Action |
Boston Scientific notified accounts by letter on 8/28/07 by Federal Express Priority mail. Accounts are requested to remove product from inventory and return product. |
Quantity in Commerce |
734 boxes |
Distribution |
Worldwide, including USA, Sweden, and South Africa. |
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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