Z-1536-2010

Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI

Name: Z-1536-2010 Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI
Creator: Davol, Inc., Sub. C. R. Bard, Inc.
Published: 2010-04-08
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2010-04-08 / Terminated / root cause: labeling and UDI

FDA source

Davol, Inc., Sub. C. R. Bard, Inc. began a recall of Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI Product Code: 0010211 The Ventrio Hernia Patch is a self-expanding non-absorbable... on 2010-04-08. The reason FDA records is "Mislabeled: Product labeled as Small Oval (3.1" x 4.7") may contain Small Circle (3.0")". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1536-2010
Status: Terminated
Initiated: 2010-04-08
Posted: 2010-05-04
Terminated: 2011-10-27
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI Product Code: 0010211 The Ventrio Hernia Patch is a self-expanding non-absorbable, sterile prosthesis, containing two primary layers of monofilament polypropylene mesh stitched with PTFE monofilament to an ePTFE sheet, forming a positioning pocket. The Ventrio Hernia Patch is 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: Product labeled as Small Oval (3.1" x 4.7") may contain Small Circle (3.0")
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: An "URGENT RECALL: BARD VENTRIO SMALL OVAL HERNIA PATCH (LOT DATB0015" letter dated April 8, 2010, was issued by the firm (Davol) to all customers via FedEx overnight with signature required. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to: please examine their inventory and immediately discontinue use of this lot; contact the Davol Customer Service Department at 1-800-556-6275 for instructions on how to return product to firm; complete and fax the EFFECTIVENESS CHECK sheet to 1-401-825-8753, and forward a copy of this letter, if they are a distributor, to their customers who have received the product and lot number. All products returned will be held at the Davol, Warwick location. Please contact your Davol Territory Manager or C.R. Bard's Medical Service Support Department at 1-800-562-0027 if you have any other questions.
Quantity in commerce: 198 units
Distribution: Nationwide distribution
Product codes and lots: REF 0010211 Lot DATB0015

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)