Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0819-2014·Announced 2014-01-29

FDA Recalls Composix L/P Mesh Due to Labeling Mismatch

Davol, Inc. is recalling 19 units of Composix L/P Mesh with Echo PS Positioning System because the product labeling does not match the product configuration.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 product labeling does not match the product configuration. No injuries or illnesses are reported, fitting the criteria for a moderate severity labeling issue.

Plain-English summary

Davol, Inc., a subsidiary of C. R. Bard, Inc., is recalling 19 units of the Composix L/P Mesh with Echo PS Positioning System, Product Code 0144113, Lot HUXH0294. The recall was initiated because the product labeling does not match the product configuration.

The affected product is a non-absorbable sterile lightweight mesh prosthesis with a preattached removable positioning system, indicated for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. The recall covers units distributed nationwide, including California, Pennsylvania, Illinois, Virginia, Florida, Georgia, New York, Texas, Missouri, Nebraska, Indiana, New Mexico, Ohio, and Iowa.

Healthcare providers and patients should contact Davol, Inc. or C. R. Bard, Inc. for further instructions regarding the return or replacement of the affected devices.

The recalled product

Product: Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the…
Manufacturer: Davol, Inc., Subs. C. R. Bard, Inc.
Category: Medical Device — Surgical Mesh
Hazard: mis-labeling
Affected units: 19

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# HUXH0294

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

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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Same hazard · mis labeling