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U.S. Department of Health and Human Services

Class 2 Device Recall BardVentralex" Hernia Patch

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  Class 2 Device Recall BardVentralex" Hernia Patch see related information
Date Initiated by Firm April 11, 2011
Date Posted May 02, 2011
Recall Status1 Terminated 3 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 Bard¿Ventralex" Hernia Patch Medium Circle with Strap Diameter 6.4cm /2.5",\
Catalog #0010302,
lot number HUTL1283.
The Bard¿Ventralex" 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/
Davol, Inc., Sub. C. R. Bard, Inc.
100 Crossings Blvd
Warwick RI 02886-2850
For Additional Information Contact SAME
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 2
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 and Original Applicant = C.R. BARD, INC.