Recall Z-0424-2011 ยท FTL Mesh, Surgical, Polymeric
Davol, Inc., Sub. C. R. Bard, Inc.
BARD Ventrio Small Circle Hernia Patch 3.0" Product Code: 0010213 Indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias.
| Date | Nov 19, 2010 (initiated Oct 15, 2010) |
| Status | Terminated |
| Reason | Mislabeled: Hernia Patch may be a different size than on the product label |
| Root cause | Packaging process control |
| Action | Davol notified accounts by an Urgent: Medical Device Recall letter on 10/15/10 via overnight delivery. The letter stated that the product maybe a different size than indicated on the product label. It also identified the affected product. Accounts are requested to examine their inventory, remove, and return recalled product. Customers are to notify any of their customers that they may have further distributed the affected product to by including a copy of the recall notice. Customers should contact Davol Customer Service 1-800-556-6275 for instructions on how to return the affected produ |
| Quantity | 26 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081777 | VENTRIO HERNIA PATCH C.R. Bard, Inc., Sep 29, 2008 |