Bard Ventralight ST Mesh Recall for Potential Sterile Pouch Seal Issues
Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile inflation assembly pouch may be open or have a 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 hazard involves a potential breach of sterile packaging without reported injuries or illnesses, 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 4.5" Circle. The product is indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
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 issue could potentially compromise the sterility of the components.
The affected lots are HUXH0535, HUXH0696, and HUXK0747. The product 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. Healthcare providers and patients should contact the manufacturer or their supplier for further instructions on handling the recalled product.
The recalled product
- Product
- Bard¿ Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 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: HUXH0535
- HUXH0696
- HUXK0747
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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