The Recall Desk
ModerateFDA (Devices)·Z-1685-2014·Announced 2014-06-11

Bard Composix LIP Mesh Recall Due to Potential Packaging Seal Defects

Davol, Inc. is recalling specific lots of Bard Composix LIP Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.

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, which is generally associated with a temporary or medically reversible adverse health consequence. The hazard is a potential packaging defect that could compromise sterility, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Davol, Inc., a subsidiary of C. R. Bard, Inc., is recalling the Bard Composix LIP Mesh with Echo PS, 7"x9" (Reorder Number: 0144790). The recall is limited to Lot Number HUXK1539. The product is indicated for the reconstruction of soft tissue deficiencies, such as the repair of hernias.

The recall was initiated because the pouch holding the sterile inflation assembly and inflation adapter may be open or have a weak seal. This defect could potentially compromise the sterile integrity of the components.

The affected product was distributed worldwide, including nationwide in the United States and internationally to Austria, Belgium, Canada, Cyprus, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, and the United Kingdom. Healthcare providers and patients should check their records for this specific lot number and contact the manufacturer or their supplier for further instructions.

The recalled product

Product
Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

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 Number: HUXK1539

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 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 15 products in this recall →

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

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