Z-2413-2012Class II

Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST...

Name: Z-2413-2012 Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST...
Creator: Davol, Inc., Subs. C. R. Bard, Inc.
Published: 2012-09-04
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2012-09-04 / Terminated / root cause: labeling and UDI

FDA source

Davol, Inc., Subs. C. R. Bard, Inc. began a recall of Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and... on 2012-09-04. FDA classified it as Class II and gives the reason as "Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh". 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-2413-2012
Classification: Class II
Status: Terminated
Initiated: 2012-09-04
Posted: 2012-09-20
Terminated: 2013-09-03
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented 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: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Davol issued an "URGENT: MEDICAL DEVICE RECALL" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter advises customers to examine their inventory and quarantine affected product for return to the firm. Customers were asked to complete and return a Recall Effectiveness Check Form. Contact Davol Customer Service Department at 1-800-556-6275 or C.R. Bard's Medical Services & Support Department at 1-800-562-0027 if you have any questions.
Quantity in commerce: 49 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot # HUWE1780

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2413-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2412-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2413-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20

Product code FTL

K101851Class IIVentralight St MeshDavol Inc., Sub. C. R. Bard, Inc. / cleared 2010-07-15

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)