Recall Z-2124-2011 ยท FTL Mesh, Surgical, Polymeric
Davol, Inc., Sub. C. R. Bard, Inc.
BardVentralex" Hernia Patch Medium Circle with Strap Diameter 6.4cm /2.5",\ Catalog #0010302, lot number HUTL1283. The BardVentralex" Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric". It is intended for use in all forms of hernia repair requiring reinforcement with a non-absorbable support material
| Date | May 2, 2011 (initiated Apr 11, 2011) |
| Status | Terminated |
| Reason | Mislabeled: Bard Medium Ventralex Hernia Patch 6.4cm /2.5" packaged in a pre-printed carton identified for a Bard Ventralex Small Circle 4.3cm /1.7" |
| Root cause | Labeling mix-ups |
| Action | Davol sent an Urgent: Medical Device Recall letter on April 11, 2011, via FedeX Priority Overnight to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and remove and return the recalled lot. Distributors were requested to notify their accounts. For questions contact the Davol Customer Service Department at 1-800-556-6275 or C. R. Bard's Medical Services & Support Department at 1-800-562-0027. |
| Quantity | 146 units |
| Distribution | Nationwide Distribution - USA including AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, MA, MD, MI, MO, MT, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021736 | BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301 C.R. Bard, Inc., Jul 16, 2002 |