Events

Recall of BARD Mesh Preshaped

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Davol, Inc., Sub. C. R. Bard, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57008
  • Event Risk Class
    Class 2
  • Event Number
    Z-0446-2011
  • Event Initiated Date
    2010-10-15
  • Event Date Posted
    2010-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95166
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    mesh, surgical, polymeric - Product Code FTL
  • 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).
  • 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.

Device

BARD Mesh Preshaped
  • Model / Serial
    Lot : HUUF0412.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution
  • Product Description
    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
  • Manufacturer
    Davol, Inc., Sub. C. R. Bard, Inc.

Manufacturer

Davol, Inc., Sub. C. R. Bard, Inc.
  • Manufacturer Address
    Davol, Inc., Sub. C. R. Bard, Inc., 100 Crossings Blvd, Warwick RI 02886-2850
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA