FDA Medical Device Recalls (openFDA)
Davol, Inc., Sub. C. R. Bard, Inc.: BARD Mesh Pre-shaped (1.8" x 4.0"/4.5cm x 10cm) Product code: 0112700 Intended use: Bard Pre-shaped mesh is a pre-shaped mesh constructed of knitted polypropylene monofilaments. It is indicated for the repair of inguinal hernia defects
- Recall number
- Z-0446-2011
- Recalling firm
- Davol, Inc., Sub. C. R. Bard, Inc.
- Product
- BARD Mesh Pre-shaped (1.8" x 4.0"/4.5cm x 10cm) Product code: 0112700 Intended use: Bard Pre-shaped mesh is a pre-shaped mesh constructed of knitted polypropylene monofilaments. It is indicated for the repair of inguinal hernia defects
- Status
- Terminated
- Initiated
- 2010-10-15
- Posted
- 2010-11-23
- Terminated
- 2011-10-27
- Reason
- Mislabeled: The labeled BARD Mesh Pre-shaped product code 0112700 (1.8" x 4.0"/4.5cm x 10cm), but the contents are the BARD Mesh Large Pre-shaped product code 0113700 (2.4" x 5.4"/6.0cm x 13.7cm).
- Root cause
- Process control
- Action
- Davol issued an "URGENT MEDICAL DEVICE RECALL" letter on October 15, 2010, via Overnight Delivery to all customers. The letter describes the product, the problem and the action to be taken by the customers. The customers were instructed to immediately examine their inventory and quaratine the product; identify and notify customers they may have further distributed the product to of this recall; contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product, and complete and return the attached EFFECTIVENESS CHECK form via fax to 1-401-825-8753. If you have an questions, please contact Davol Customer Service Department at 1-800-556-6275 or C. R. Bard's Medical Service Support Department at 1-800-562-0027.
- Quantity
- 144 units
- Distribution
- Nationwide distribution
- Lot, serial or model codes
- Lot : HUUF0412.
- 510(k) numbers
- ["K052155"]
- 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