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U.S. Department of Health and Human Services

Class 2 Device Recall Bard Ventralex" ST Medium Circle with Strap Hernia Patch

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  Class 2 Device Recall Bard Ventralex" ST Medium Circle with Strap Hernia Patch see related information
Date Initiated by Firm October 04, 2011
Date Posting Updated November 01, 2011
Recall Status1 Terminated 3 on September 20, 2013
Recall Number Z-0144-2012
Recall Event ID 60057
510(K)Number K101928  
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product Bard¿ Ventralex" ST Medium Circle with Strap Hernia Patch Diameter 6.4cm /2.5", Catalog Number: 5950008.

Intended for use in the reconstruction of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair hernias and deficiencies caused by trocars.
Code Information Lot number: HUVD1253.
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¿ Ventralex" ST Medium Circle was packaged in a pre-printed carton identified for a Bard¿ Ventralex" ST Large Circle.
FDA Determined
Cause 2
Packaging process control
Action Davol Inc. issued an Urgent; Medical Device Recall letter on 10/4/11 for the mislabeled Bard Ventralex ST Medium Circle. The letter identified the affected product and explained the reason for recall. Customers are to immediately examine their inventory and quarantine any affected product. In addition, if any product was further distributed then those customers should be notified of the recall as well. Accounts are to contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product to Davol. The attached recall effectiveness check form should be completed and returned. Questions should be directed towards 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 96 units
Distribution Nationwide Distribution
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.
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