Events

Recall of BD

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Company.

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
    52023
  • Event Risk Class
    Class 2
  • Event Number
    Z-1488-2009
  • Event Initiated Date
    2009-04-30
  • Event Date Posted
    2009-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81923
  • 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 - Product Code FMF
  • Reason
    Potential for compromised sterility: insufficient packaging seals.
  • Action
    Becton Dickinson sent Urgent Product Recall letters on April 30, 2009 to all direct customers. Questions are to be directed to BD Customer Service at 1-888-237-2762. Letters to customers of distributors went out on May 12, 2009.

Device

BD
  • Model / Serial
    Catalog Number 309661: Lot numbers: 9065361, 9065362, 9065366, 9065367, 9065380.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    BD 20 ml Syringe || Luer-Lok Tip || Sterile, Do not reuse; Catalog Number 309661.
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Manufacturer Address
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA