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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 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
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/
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact
Manufacturer Reason
for Recall
Device lacked manufacturing finishing process resulting in endoscope damage.
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

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.