Events

Recall of Device Recall Bard/Davol

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
    50479
  • Event Risk Class
    Class 3
  • Event Number
    Z-0935-2009
  • Event Initiated Date
    2008-12-08
  • Event Date Posted
    2009-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75464
  • 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
    Surgical mesh - Product Code FTL
  • Reason
    Mislabeled: product labeled as left large, may contain a right large.
  • Action
    Davol issued a letter notification dated 12/25/08 via Federal Express requesting accounts discontinue use, remove product from inventory and return product. For additional information, contact Davol at 1-401-463-7000.

Device

Device Recall Bard/Davol
  • Model / Serial
    Lot Code: 43JQD016
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Bard 3D Max Mesh, Left large , Sterile || Pre-formed Knitted Polypropylene || Product Code: 0151531 || Bard 3D Max Mesh is an anatomically shaped pre-formed polypropylene mesh indicated for use in the repair of hernias and chest wall defects. It is designated in two orientations - "Right" and "Left" for use to the right or left side of the human body. There is a blue monofilament Medial marker "M" and a small arrow stitched into each orientation to designate the right or left medial edge of the product
  • 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