Events

Recall of Bard

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bard Endoscopic Technologies.

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
    26909
  • Event Risk Class
    Class 2
  • Event Number
    Z-1231-03
  • Event Initiated Date
    2003-08-04
  • Event Date Posted
    2003-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28724
  • 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
    Syringe, Piston - Product Code FMF
  • Reason
    Mislabeled kit: prefilled lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile.
  • Action
    Bard Endoscopic notified customerson 8/4/03, by Recall Notice sent by registered mail, along with an Effectivity Form that each Bard account will complete and return. Product will be returned to Bard Endoscopic. 5. The BET Recall Coordinator will track effectivity, and phone accounts that have either not returned the Effectivity Form or whose letter had been returned as undeliverable.

Device

Bard
  • Model / Serial
    Lot number: 43FNA086
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide AZ, AL, CA, CO, CT, FL, GA, KY, IN, IL, KS, LA, MA, MD, MS, MN, MO, NH, NJ, NY, OH, MI, MO, PA, RI, TN, TX, VA, VT , WA Govt: VA MEDICAL CENTER/CC 800 HOSPITAL DR. COLUMBIA MO 06050
  • Product Description
    Bard Ponsky PEG Safety System ''Pull'' || Reorder Number: 001925
  • Manufacturer
    Bard Endoscopic Technologies

Manufacturer

Bard Endoscopic Technologies
  • Manufacturer Address
    Bard Endoscopic Technologies, 129 Concord Road, Building #3, Billerica MA 01821-7031
  • Source
    USFDA