FDA Medical Device Recalls (openFDA)
Davol, Inc., Subs. C. R. Bard, Inc.: Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
- Recall number
- Z-2413-2012
- Recalling firm
- Davol, Inc., Subs. C. R. Bard, Inc.
- Product
- Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
- Status
- Terminated
- Initiated
- 2012-09-04
- Posted
- 2012-09-20
- Terminated
- 2013-09-03
- Reason
- Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh
- Root cause
- Mixed-up of materials/components
- Action
- Davol issued an "URGENT: MEDICAL DEVICE RECALL" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter advises customers to examine their inventory and quarantine affected product for return to the firm. Customers were asked to complete and return a Recall Effectiveness Check Form. Contact Davol Customer Service Department at 1-800-556-6275 or C.R. Bard's Medical Services & Support Department at 1-800-562-0027 if you have any questions.
- Quantity
- 49 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lot # HUWE1780
- 510(k) numbers
- ["K101851"]
- PMA numbers
- not on file
- Product code
- FTL
- Firm FEI
- 1213643
- Firm city
- Warwick
- Firm state
- RI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28