Recall Z-0144-2012 ยท FTL Mesh, Surgical, Polymeric
Davol, Inc., Sub. C. R. Bard, Inc.
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.
| Date | Nov 1, 2011 (initiated Oct 4, 2011) |
| Status | Terminated |
| Reason | Mislabeled: Bard Ventralex" ST Medium Circle was packaged in a pre-printed carton identified for a Bard Ventralex" ST Large Circle. |
| Root cause | 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 re |
| Quantity | 96 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101928 | VENTRALEX ST HERNIA PATCH C.R. Bard, Inc., Mar 23, 2011 |