Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1696-2014·Announced 2014-06-11

Bard Ventralight ST Mesh Recalled for 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 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 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential loss of sterility due to a packaging defect, which fits the criteria for a moderate risk where harm has not yet been reported.

Plain-English summary

Davol, Inc., a subsidiary of C. R. Bard, Inc., is recalling the Bard Ventralight ST Mesh with Echo PS 8"x10" (Reorder Number: 5955810). The recall involves specific lots identified by the numbers HUXH0691, HUXL0336, HUXL0495, HUXL0660, HUXL1006, HUXL1007, and HUXL 1147. The product is indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

The reason for the recall is that 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 products were distributed worldwide, including 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 facilities should check their inventory for these specific lot numbers and stop using the affected products.

The recalled product

Product: Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 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: sterility-compromise
packaging-defect

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 (7)

Lot Number: HUXH0691
HUXL0336
HUXL0495
HUXL0660
HUXL1006
HUXL1007
HUXL 1147

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 →

Same manufacturer · Davol, Inc., Subs. C. R. Bard, Inc.

See all →

Moderate
Bard PerFix Light Plug Recalled for Labeling Mismatch
FDA (Devices) · 2014-11-19
Moderate
Bard Composix LIP Mesh Recall Due to Potential Packaging Seal Defects
FDA (Devices) · 2014-06-11
Moderate
Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Failure
FDA (Devices) · 2014-06-11
High
Bard Composix LIP Mesh Recall Due to Potential Sterility Compromise
FDA (Devices) · 2014-06-11
Moderate
Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Defects
FDA (Devices) · 2014-06-11

Same hazard · sterility compromise