Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Defects
Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile pouch holding the inflation assembly may have an open or weak seal.
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, and the source text describes a potential packaging defect (weak seal) without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Davol, Inc., a subsidiary of C. R. Bard, Inc., is recalling specific lots of Bard Ventralight ST Mesh with Echo PS 10"x13" (Reorder Number: 5955113). The product is indicated for use in 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 lots are HUXK0900, HUXK0901, and HUXL1148. These products were 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. Healthcare providers and patients should contact the manufacturer for further instructions on how to proceed with the affected devices.
The recalled product
- Product
- Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 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 (3)
- Lot Number: HUXK0900
- HUXK0901
- HUXL1148
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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