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.
FDA Recall Z-0144-2012 · Posted 2011-11-01
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Recalling FirmDavol, Inc., Sub. C. R. Bard, Inc.
Recall StatusTerminated
Product CodeFTL
Date Initiated2011-10-04
Date Terminated2013-09-20
Product Quantity96 units
Reason for Recall
Mislabeled: Bard Ventralex" ST Medium Circle was packaged in a pre-printed carton identified for a Bard
Ventralex" ST Large Circle.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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