Events

Recall of Microtainer Safety Flow Lancets

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
    44940
  • Event Risk Class
    Class 2
  • Event Number
    Z-0044-2008
  • Event Date Posted
    2007-10-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-01-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64555
  • 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
    Lancets - Product Code FMK
  • Reason
    Potential for the blade and holder assembly to become loose and then separate from the main body of the lancet during the process of disposal.
  • Action
    Recall communication issued on or about 9/28/2007.

Device

Microtainer Safety Flow Lancets
  • Model / Serial
    Catalog Number 366356 Lot numbers: 2340296, 2353789, 3007400, 3043001, 3073415, 3100407, 3198493.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product distributed worldwide to Australia, Brazil, Canada, China, Colombia, Guatemala, Hong Kong, India, Indonesia, Mexico, Malaysia, New Zealand, Pakistan, Philippines, Singapore, Thailand, and United States.
  • Product Description
    Microtainer Safety Flow Lancets; Green || Sterile, Use Once and Discard; || 1.4 mm Blade Length; || 1.0mm Blade Width; || Becton Dickinson Vacutainer Systems; || Becton Dickinson & Company; || Franklin Lakes, NJ 07417
  • 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