The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0820-2014·Announced 2014-01-29

FDA Recalls Composix L/P Mesh Due to Labeling Mismatch

Davol, Inc. is recalling 46 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 due to a labeling error (labeling does not match product configuration). Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity category.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 46 units of the Composix L/P Mesh with Echo PS Positioning System, Product Code 0144680. The product is a non-absorbable sterile lightweight mesh prosthesis indicated for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. The recall is being conducted by Davol, Inc., a subsidiary of C. R. Bard, Inc.

The reason for the recall is that the product labeling does not match the product configuration. The affected lots are HUXG0491 and HUXH0295. The products were distributed nationwide, including to California, Pennsylvania, Illinois, Virginia, Florida, Georgia, New York, Texas, Missouri, Nebraska, Indiana, New Mexico, Ohio, and Iowa.

Healthcare providers and patients who have received this specific product should contact Davol, Inc. or C. R. Bard, Inc. for further instructions on how to return the product or obtain a replacement. The FDA advises that this recall is a Class II, which means the use of or exposure to the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Composix L/P with Echo PS 6" X 8" Product Code 0144680 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 reconstruction…
Manufacturer
Davol, Inc., Subs. C. R. Bard, Inc.
Category
Medical Device — Surgical Mesh
Hazard
Affected units
46

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 (2)

  • Lot# HUXG0491
  • HUXH0295

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 →

Related recalls

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

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Same hazard · mis labeling

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