Class 2 Device Recall Bard Dimension Stone Basket

• Date Initiated by Firm: October 07, 2014
• Date Posted: October 31, 2014
• Recall Status: Terminated on June 12, 2015
• Recall Number: Z-0163-2015
• Recall Event ID: 69462
• Product Classification: Dislodger, stone, basket, ureteral, metal - Product Code FFL
• Product: Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle, shaft and basket. It is intended to use in the endoscopic removal of renal and ureteral stones.
• Code Information: Product code: 042316, Lot number: BMXJM031
• Recalling Firm/ Manufacturer: C.R. Bard, Inc.; 8195 Industrial Blvd Ne; Covington GA 30014-1497
• For Additional Information Contact: Sherry Saurini; 770-784-6120
• Manufacturer Reason for Recall: The product is non-sterile.
• FDA Determined Cause: Release of Material/Component prior to receiving test results
• Action: Bard sent an Urgent: Medical Device Recall letter to each customer on 10/7/2014 with proof of delivery notice. Wholesalers were asked to conduct a sub-recall. Letter identify the affected product, problem and actions to be taken. Customers were instructed to examine their inventory and quarantine product subject to recall, do not use or further distribute any of the affected product, remove and return affected product to Bard Medical Division, and if the product have been further distributed identify your customers and notify them at once of the product recall. Customers were instructed to complete the enclosed Recall & Effectiveness Check Form and fax to 1-770-784-6469. For questions call 1-770-784-6471.
• Quantity in Commerce: 86 units
• Distribution: Worldwide Distribution in the states of AL, FL, NJ, NY, NC, PA, SC, TX, WI, and countries of Germany, Italy, Kuwait, and Luxembourg.
• 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.