Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Defects
Davol, Inc. is recalling Composix LP hernia mesh because the sterile packaging may have weak seals, potentially compromising sterility.
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 the hazard involves a potential loss of sterility due to packaging defects, which fits the criteria for moderate severity without reported injuries.
Plain-English summary
Davol, Inc., a subsidiary of C. R. Bard, Inc., is recalling specific lots of Composix LP with Echo PS 6x8 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.
The affected product is indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. The specific lots involved are HUXK0073 and HUXK1537, with reorder number 0144680.
The product was distributed nationwide in the United States and internationally to numerous countries, including Austria, Belgium, Canada, and the United Kingdom. Healthcare providers and patients should check their records for these specific lot numbers and contact the manufacturer or their supplier for instructions on replacement or return.
The recalled product
- Product
- Composix" LP with Echo PS" 6 x8 Reorder Number: 0144680 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 — Surgical 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)
- Lot Number: HUXK0073
- HUXK1537
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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