The Recall Desk
ModerateFDA (Devices)·Z-2412-2012·Announced 2012-09-26

FDA Recalls Mislabeled Bard Ventralight ST Mesh Surgical Products

Davol, Inc. is recalling 49 units of Bard Ventralight ST Mesh due to size mislabeling on the packaging.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error (size mismatch) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Davol, Inc., a subsidiary of C. R. Bard, Inc., is recalling 49 units of Bard Ventralight ST Mesh, Product Code 5954810, Lot # HUWE1779. The device is a dual-component sterile prosthesis intended for the reconstruction of soft tissue deficiencies, such as hernia repair. The recall is due to a labeling error where the 8" x 10" package contains 7" x 9" mesh, and the 7" x 9" package contains 8" x 10" mesh.

The affected products were distributed nationwide. The source text does not specify specific dates of distribution or the number of units sold to end-users, only the total quantity of 49 units involved in the recall.

Consumers and healthcare providers should stop using the affected mesh and contact the recalling firm for instructions on return or replacement. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. 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
Affected units
49

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot # HUWE1779

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Davol, Inc., Subs. C. R. Bard, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Davol, Inc., Subs. C. R. Bard, Inc.

See all →