Events

Recall of Device Recall Bard 100 LatexFree Urinary Drainage Bag with AntiReflux Chamber and Bard EXLok Sampling

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 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
    70666
  • Event Risk Class
    Class 2
  • Event Number
    Z-1358-2015
  • Event Initiated Date
    2015-01-30
  • Event Date Posted
    2015-04-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134365
  • 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
    Collector, urine, (and accessories) for indwelling catheter - Product Code KNX
  • Reason
    Potential breach of the sterile barrier packaging.
  • Action
    Bard sent an Urgent Medical Device Recall letter on January 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter also requested that a sub-recall should be conducted if the product was further distributed. The letter also included a response form which is to be returned to Bard. This voluntary recall is only for the lots noted above with the affected product catalog number. Notifications of this recall are being sent to all affected accounts of Bard Medical Division, Inc. If you have further distributed this product, you are required to notify your accounts of the voluntary recall. If you have any questions or need assistance in notifying your accounts about the correction, please call 1-770-784-6471. We appreciate your cooperation and assistance in dealing with this matter and sincerely apologize for any inconvenience that may result from this action.

Device

Device Recall Bard 100 LatexFree Urinary Drainage Bag with AntiReflux Chamber and Bard EXLok Sam...
  • Model / Serial
    Lot Numbers NGYJ0603 and NGYJ1671
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to the states of : AL, AZ, CA, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VA, WV and WA.
  • Product Description
    Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671
  • Manufacturer
    C.R. Bard, Inc.

Manufacturer

C.R. Bard, Inc.
  • Manufacturer Address
    C.R. Bard, Inc., 8195 Industrial Blvd Ne, Covington GA 30014-1497
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA