Class 2 Device Recall BardVentralex" Hernia Patch

• Date Initiated by Firm: April 11, 2011
• Date Posted: May 02, 2011
• Recall Status: Terminated on October 27, 2011
• Recall Number: Z-2124-2011
• Recall Event ID: 58470
• 510(K)Number: K021736
• Product Classification: Mesh, surgical, polymeric - Product Code FTL
• Product: BardVentralex" Hernia Patch Medium Circle with Strap Diameter 6.4cm /2.5",\ Catalog #0010302, lot number HUTL1283. The BardVentralex" Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric". It is intended for use in all forms of hernia repair requiring reinforcement with a non-absorbable support material
• Code Information: Lot number HUTL1283
• Recalling Firm/ Manufacturer: Davol, Inc., Sub. C. R. Bard, Inc.; 100 Crossings Blvd; Warwick RI 02886-2850
• For Additional Information Contact: SAME; 401-825-8633
• Manufacturer Reason for Recall: Mislabeled: Bard Medium Ventralex Hernia Patch 6.4cm /2.5" packaged in a pre-printed carton identified for a Bard Ventralex Small Circle 4.3cm /1.7"
• FDA Determined Cause: Labeling mix-ups
• Action: Davol sent an Urgent: Medical Device Recall letter on April 11, 2011, via FedeX Priority Overnight to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and remove and return the recalled lot. Distributors were requested to notify their accounts. For questions contact the Davol Customer Service Department at 1-800-556-6275 or C. R. Bard's Medical Services & Support Department at 1-800-562-0027.
• Quantity in Commerce: 146 units
• Distribution: Nationwide Distribution - USA including AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, MA, MD, MI, MO, MT, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, and WV.
• 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 = FTL