Class 2 Device Recall Boston Scientific

• Date Initiated by Firm: August 28, 2007
• Date Posted: October 31, 2007
• Recall Status: Terminated on July 10, 2008
• Recall Number: Z-0116-2008
• Recall Event ID: 44736
• Product Classification: Biopsy Forceps - Product Code FFF
• Product: Boston Scientific Radial Jaw Large Capacity Biopsy Forceps, Sterile, 240 mm. Box of 20 U PN Number: M00513321 REF: 1332-20
• Code Information: Lot Number: 8990184
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: 508-650-8798
• Manufacturer Reason for Recall: Device lacked manufacturing finishing process resulting in endoscope damage.
• FDA Determined Cause: 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: 145 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.