Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Issues
Davol, Inc. is recalling Composix LP hernia mesh because the sterile packaging may have weak seals, 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, but the source text describes a packaging defect (weak seal) without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or precautionary measures where harm is theoretical.
Plain-English summary
Davol, Inc., a subsidiary of C. R. Bard, Inc., is recalling specific lots of Composix LP with Echo PS hernia mesh. The recall is due to a defect where 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 barrier of the medical device.
The affected products are indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. The specific product codes involved in this recall are HUXH0294 and HUXL0314. The products were distributed worldwide, including nationwide in the United States and internationally to numerous countries in Europe, Canada, and South Africa.
Healthcare providers and patients should check their inventory and records for these specific product codes. If the packaging is found to be open or has a weak seal, the device should not be used. Users should contact the manufacturer for further instructions on how to handle the affected units.
The recalled product
- Product
- Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
- Manufacturer
- Davol, Inc., Subs. C. R. Bard, Inc.
- Category
- Medical Device — Hernia Mesh
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)
- HUXH0294
- HUXL0314
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.
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