Events

Recall of Device Recall Bard

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
    34393
  • Event Risk Class
    Class 1
  • Event Number
    Z-0761-06
  • Event Initiated Date
    2005-12-22
  • Event Date Posted
    2006-02-22
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44996
  • 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
    Hernia repair device - Product Code FTL
  • Reason
    Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula. (extension of recall z-0524/0526-06).
  • Action
    Davol Inc. notified US Customers by letter on 12/27/05 via Federal Express. Bard Regulatory International was notified 12/22/05 to recall to accounts outside the US. Accounts are requested to return recalled product. A second letter issued dated January 5, 2006 to include additional product codes not identified in the first letter, specifically to the accounts that received those lots. On 3/24 / 06, Davol issued a third Recall Notification for the extended recall to Hospitals and Distributors and a Dear Doctor Letter to Chief of Surgery.

Device

Device Recall Bard
  • Model / Serial
    Lot Numbers: 41*L****, 41*M****, 41*N**** 43*L****, 43*M****, 43*N****
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Foreign: Australia, Canada, Japan,
  • Product Description
    Bard¿ Composix¿ Kugel Large Circle, 4.5'' for hernia repairs || Product Code: 0010204
  • 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 Sockanossett Crossroad, Cranston RI 02920
  • Source
    USFDA