Z-0424-2011

BARD Ventrio Small Circle Hernia Patch 3.0"

Name: Z-0424-2011 BARD Ventrio Small Circle Hernia Patch 3.0"
Creator: Davol, Inc., Sub. C. R. Bard, Inc.
Published: 2010-10-15
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2010-10-15 / Terminated / root cause: packaging

FDA source

Davol, Inc., Sub. C. R. Bard, Inc. began a recall of 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... on 2010-10-15. The reason FDA records is "Mislabeled: Hernia Patch may be a different size than on the product label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0424-2011
Status: Terminated
Initiated: 2010-10-15
Posted: 2010-11-19
Terminated: 2011-10-27
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: 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.
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: Mislabeled: Hernia Patch may be a different size than on the product label
Root cause tag: packaging
FDA 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 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.
Quantity in commerce: 26 units
Distribution: Nationwide Distribution
Product codes and lots: Lot Number: HUUH1088

Product code FTL

K081777Class IIVentrio Hernia PatchC.R. Bard, Inc. / cleared 2008-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)