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.
This recall has been terminated (originally issued November 1, 2011).
- Recall Initiated
- October 4, 2011
- Posted
- November 1, 2011
- Terminated
- September 20, 2013
- Recall Number
- Z-0144-2012
- Quantity
- 96 units
- Firm Location
- Warwick, RI
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeled: Bard Ventralex" ST Medium Circle was packaged in a pre-printed carton identified for a Bard Ventralex" ST Large Circle.
Distribution
Nationwide Distribution
Lot / Code Info
Lot number: HUVD1253.
Root Cause
Packaging process control
Action Taken
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.