Events

Recall of Device Recall Bard DispozABag

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

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
    25894
  • Event Risk Class
    Class 2
  • Event Number
    Z-0732-03
  • Event Initiated Date
    2003-03-25
  • Event Date Posted
    2003-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26681
  • 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
    Bag, Urine Collection, Leg, For External Use, Sterile - Product Code FAQ
  • Reason
    There is a potential for package seals to be open after sterilization.
  • Action
    The oldest lot that the firm has confirmed in inventory that had an open seal was manufactured in October 2002. Based upon depletion analysis with distributor inventory being three months and an additional assurance of 12 months, the firm is removing product manufactured from October 1, 2001 through February 28, 2003. Consignees were notified via certified letter with Business Reply Form attached for effectiveness check. Consignees were advised to remove/segregate, and return affected product for credit.

Device

Device Recall Bard DispozABag
  • Model / Serial
    Catalogue #150719, 150732, 150819, 150832, Lot numbers beginning with 76JL through 76BN.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to 16 doctors, 79 hospitals, 280 distributors, and 53 sales representatives nationwide.
  • Product Description
    Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, C.R.Bard, Inc., Covington, GA 30014, Contents Sterile.
  • Manufacturer
    C.R. Bard, Inc., Urological Division

Manufacturer

C.R. Bard, Inc., Urological Division
  • Manufacturer Address
    C.R. Bard, Inc., Urological Division, 8195 Industrial Blvd NE, Covington GA 30014
  • Source
    USFDA