Class 2 Device Recall Bard UroForce

• Date Initiated by Firm: November 03, 2005
• Date Posted: December 03, 2005
• Recall Status: Terminated on January 24, 2006
• Recall Number: Z-0268-06
• Recall Event ID: 34037
• 510(K)Number: K993840
• Product Classification: Dilator, Catheter, Ureteral - Product Code EZN
• Product: Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO
• Code Information: Catalog #887504, Lot #GFPG2394; Catalog #887510, Lot #GFPG2399; Catalog #887604, GFPG2401, GFPG2402, GFPG2403, GFPG2404, GFPG2405, GFPG2424; Catalog #887610, Lot #GFPF3439, GFPG2406; Catalog #888404, Lot #GFPG2409, Catalog #888604, Lot #GFPG2411, GFPH1415; Catalog #888510, Lot #GFPG2415, GFPH2024; Catalog #888604, Lot #GFPG2417, GFPG2418; Catalog #888610, Lot #GFPF3451.
• Recalling Firm/ Manufacturer: C.R. Bard, Inc., Urological Division; 8195 Industrial Blvd Ne; Covington GA 30014-1497
• For Additional Information Contact: John C. Knorpp; 770-874-6451
• Manufacturer Reason for Recall: There is a potential for the lumen to collapse and prevent passage over a guidewire.
• FDA Determined Cause: Other
• Action: Consignees were notified via overnight courier on 11/7&8/2005
• Quantity in Commerce: 480 units
• Distribution: Nationwide, Belgium, Canada
• 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.

• 510(K) Database: 510(K)s with Product Code = EZN