Z-2124-2011

BardVentralex" Hernia Patch Medium Circle with Strap Diameter 6.4cm /2.5",\ Catalog #0010302, lot number...

Name: Z-2124-2011 BardVentralex" Hernia Patch Medium Circle with Strap Diameter 6.4cm /2.5",\ Catalog #0010302, lot number...
Creator: Davol, Inc., Sub. C. R. Bard, Inc.
Published: 2011-04-11
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2011-04-11 / Terminated / root cause: labeling and UDI

FDA source

Davol, Inc., Sub. C. R. Bard, Inc. began a recall of BardVentralex" Hernia Patch Medium Circle with Strap Diameter 6.4cm /2.5",\ Catalog #0010302, lot number HUTL1283. The BardVentralex" Hernia Patch is a... on 2011-04-11. The reason FDA records is "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"". 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-2124-2011
Status: Terminated
Initiated: 2011-04-11
Posted: 2011-05-02
Terminated: 2011-10-27
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: 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
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Lot number HUTL1283

Product code FTL

K021736Class IIBard Ventralex Hernia Patch, Models 0010302, 0010301C.R. Bard, Inc. / cleared 2002-07-16

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)