FDA Medical Device Recalls (openFDA)
Davol, Inc., Subs. C. R. Bard, Inc.: Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.
- Recall number
- Z-0819-2014
- Recalling firm
- Davol, Inc., Subs. C. R. Bard, Inc.
- Product
- Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.
- Status
- Terminated
- Initiated
- 2014-01-03
- Posted
- 2014-01-23
- Terminated
- 2015-12-23
- Reason
- Product labeling does not match product configuration.
- Root cause
- Labeling Change Control
- Action
- Davol, Inc., Subs. C. R. Bard, Inc.sent a customer notification letter on January 3, 2013, to all affected customers via Fedex to inform consignees that the Instructions for Use (IFU) and graphic contained on the inside of the product carton bottom references two features added to the inflation tube that are not present on the product they received. Please contact the Davol Customer Service Department at 1-800-556-6275 or C. R. Bards Medical Services & Support Department at 1-800-562-0027 if you have any questions. Consignees are asked to complete an effectiveness check form and return it via fax to 401-825-8753. For questions regarding this recall call 800-556-6275,
- Quantity
- 19
- Distribution
- Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.
- Lot, serial or model codes
- Lot# HUXH0294
- 510(k) numbers
- ["K102766"]
- 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