Class 2 Device Recall Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps

• Date Initiated by Firm: May 06, 2010
• Date Posted: June 04, 2010
• Recall Status: Terminated on September 20, 2011
• Recall Number: Z-1772-2010
• Recall Event ID: 55740
• Product Classification: Forceps, biopsy, non-electric - Product Code FCL
• Product: Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Inner Pouch 240cm, Box 20 UPN/Catalog Number: M00513331
• Code Information: Lot : 13244654
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: SAME; 508-683-8000
• Manufacturer Reason for Recall: Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result.
• FDA Determined Cause: Process control
• Action: Boston Scientific issued Recall notification letters via Federal Express Priority mail on May 6, 2010. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. In the letter, customers with questions are provided with a phone and email at the firm to contact.
• Quantity in Commerce: 320 units
• Distribution: Nationwide; Panama.
• 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.