FDA Medical Device Recalls (openFDA)
Davol, Inc., Sub. C. R. Bard, Inc.: Bard Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010. The Bard Soft Mesh patch is a non-absorbable, sterile prosthesis. It has a large pore design and is constructed of knitted polypropylene monofilaments. The device classification name is "Mesh, Surgical, Polymeric".
- Recall number
- Z-2239-2011
- Recalling firm
- Davol, Inc., Sub. C. R. Bard, Inc.
- Product
- Bard Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010. The Bard Soft Mesh patch is a non-absorbable, sterile prosthesis. It has a large pore design and is constructed of knitted polypropylene monofilaments. The device classification name is "Mesh, Surgical, Polymeric".
- Status
- Terminated
- Initiated
- 2011-04-25
- Posted
- 2011-05-23
- Terminated
- 2011-10-28
- Reason
- Mislabeling: complaints of product labeled as Bard Soft Mesh 4" x 6" containing Bard Soft Mesh 6" x 6"
- Root cause
- Labeling mix-ups
- Action
- Davol issued an URGENT: MEDICAL DEVICE RECALL notification letter to customers dated April 25, 2011, informing them the recall involving a single lot of the BARD Soft Mesh - Lot# HUUF0530. This recall has been initiated because this lot number may contain a different size patch than is indicated. Customers were instructed to immediately examine inventory and quarantine product subject to recall. Customers are asked to identify and notify their customers to whom recalled product may have been further distributed. A Recall Effectiveness Check reply form should be completed and returned to Davol via fax (401-825-8753). For directions on returning product or for questions regarding the recall, contact Davol Customer Service Department at 1-800-556-6275 or C.R. Bard's Medical Services & Support Department at 1-800-562-0027.
- Quantity
- 198 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot# HUUF0530
- 510(k) numbers
- ["K033814"]
- 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