Bard Composix LIP Mesh Recall Due to Potential Sterility Compromise
Davol, Inc. is recalling Bard Composix LIP Mesh with Echo PS because the sterile inflation assembly packaging may be open or have a weak seal.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential sterility breach in a medical device, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Davol, Inc., a subsidiary of C. R. Bard, Inc., is recalling the Bard Composix LIP Mesh with Echo PS, 8"x10" (Reorder Number: 0144810). This medical device is indicated for the reconstruction of soft tissue deficiencies, such as the repair of hernias.
The recall is being conducted 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 sterility of the components.
The affected product, Lot Number HUXK1540, was distributed 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. Users should contact the manufacturer for further instructions regarding the return or replacement of the affected units.
The recalled product
- Product
- Bard¿ Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 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
- Hazard
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: HUXK1540
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 →Related recalls
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