Recall of BD AutoShield Pen Needle

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
    37900
  • Event Risk Class
    Class 2
  • Event Number
    Z-0838-2007
  • Event Initiated Date
    2007-04-23
  • Event Date Posted
    2007-05-24
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2008-04-16
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Hypodermic Needle - Product Code FMI
  • Reason
    Needle sticks: complaints were received regarding needle stick injuries while administering insulin to patients. (labeling will be revised to provide clear direction on product usage).
  • Action
    April 23, 2007, Recall letters were sent via UPS 2nd day air and/or hand delivered to all direct consignees and potential customers of the product.

Device

  • Model / Serial
    Reorder Number 329300
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide :Distribution centers in NJ, MO, TX, OH, NM, IL, ND, FL, KS, VA, LA, and GA.
  • Product Description
    BD AutoShield Pen Needle (Re order Number : 329300)
  • Manufacturer

Manufacturer

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