The Recall Desk
ModerateFDA (Devices)·Z-1692-2014·Announced 2014-06-11

Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Issues

Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile pouch holding the inflation assembly may have a weak seal or be open.

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 defect involves a potential breach of sterile packaging. As no injuries or illnesses are reported in the source text, this fits the criteria for a moderate severity recall involving a risk of harm where injury has not yet been reported.

Plain-English summary

Davol, Inc., a subsidiary of C. R. Bard, Inc., is recalling specific lots of Bard Ventralight ST Mesh with Echo PS 6"x10". 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 recall covers Lot Numbers HUXK0744 and HUXL1004. 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 stop using the affected lots and contact the manufacturer for further instructions. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product
Bard¿ Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

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: HUXK0744
  • HUXL1004

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.

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