The Recall Desk
ModerateFDA (Devices)·Z-2413-2012·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 packaging mislabeling where product sizes do not match package labels.

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 labeling error where the physical product size does not match the package label. This is a significant labeling error that could lead to improper surgical use, fitting the criteria for a moderate severity recall.

Plain-English summary

Davol, Inc., a subsidiary of C. R. Bard, Inc., is recalling 49 units of Bard Ventralight ST Mesh, Product Code 5954790, Lot # HUWE1780. The recall is due to mislabeling of the product packaging. Specifically, the 8" x 10" packages contain 7" x 9" mesh, and the 7" x 9" packages contain 8" x 10" mesh.

The Bard Ventralight ST Mesh is a sterile, dual-component prosthesis intended for the reconstruction of soft tissue deficiencies, such as hernia repair. The affected units were distributed nationwide.

Healthcare providers and patients should stop using the affected lots and contact the manufacturer for instructions on return or replacement. This recall is classified as Class II by the FDA.

The recalled product

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 i
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 # HUWE1780

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.

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