Class 3 Device Recall Boston Scientific Radial Jaw Biopsy Forceps

• Date Initiated by Firm: September 03, 2002
• Date Posted: February 21, 2003
• Recall Status: Terminated on April 15, 2008
• Recall Number: Z-0562-03
• Recall Event ID: 25510
• Product: Boston Scientific Microvasive Radial Jaw 3 Single-Use Maximum Capacity Biopsy Forceps Needle, 240 cm length, 3.3 mm Jaw Outside Diameter. Each device is pakaged in a Tyvek laminate pouch. The pouch assemblies are packaged in a five-pack product box.
• Code Information: The code for the individual pouches is Catalog 1589 and Lot # 0551847, expiration date of 2005-07. The code for the five pack boxes is Catalog No. 1589 and lot number 0551847, expiration date of 2005-07.
• Recalling Firm/ Manufacturer: Symbiosis Corp.; 8600 NW 41th Street; Miami FL 33166
• Manufacturer Reason for Recall: Product does not have the needle component as part of the jaw assembly.
• FDA Determined Cause: Other
• Action: The firm forwarded recall letters and response forms via Federal Express to Risk Managers at hospitals on 9/3/2002. Accounts were asked to return product by first calling 1-800-862-1284.
• Quantity in Commerce: 155/5-pack
• Distribution: Product was distributed to 29 hospital accounts nationwide. There were no intenational, govenment or military accounts.

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.