BARD Ventrio Large Oval Hernia Patch 5.4" x 7.0" Product Code: 0010212 Indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias.
FDA Recall Z-0423-2011 · Posted 2010-11-19
Recalling FirmDavol, Inc., Sub. C. R. Bard, Inc.
Recall StatusTerminated
Product CodeFTL
Date Initiated2010-10-15
Date Terminated2011-10-27
Product Quantity184 units
Reason for Recall
Mislabeled: Hernia Patch may be a different size than on the product label
Firm 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 product. Customers are also requested to complete and fax back the attached fax sheet to 1-401-825-8753. If there are any additional questions, customers should contact Davol Customer Service Department at 1-800-556-6275 or C.R. Bard's Medical Service 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.