The Recall Desk
HighFDA (Devices)·Z-1694-2014·Announced 2014-06-11

Bard Ventralight ST Mesh Recall Due to Potential Sterility Compromise

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

What this means for you

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 breach of sterility in a medical device used for surgical repair, which poses a risk of harm (infection) even though specific injuries are not reported in the source text.

Plain-English summary

Davol, Inc., a subsidiary of C. R. Bard, Inc., is recalling the Bard Ventralight ST Mesh with Echo PS TM 7"x9" (Reorder Number: 5955790). 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 mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

The affected product is identified by Lot Number HUXK0899. The recall covers products 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 of this product. Users should contact the manufacturer or their supplier for further instructions on how to proceed with the recall.

The recalled product

Product
Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 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 (1)

  • Lot Number: HUXK0899

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 →