Events

Recall of Device Recall BD Microtainer Quikheel Lancet

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
    66031
  • Event Risk Class
    Class 2
  • Event Number
    Z-2192-2013
  • Event Initiated Date
    2013-07-10
  • Event Date Posted
    2013-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121295
  • 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
    Lancet, blood - Product Code FMK
  • Reason
    The lancet will not retract after activation thus creating a potential for exposure to a used sharp.
  • Action
    BD notified their customers and distributors by phone, e-mail, and/or letter/notice of return/ customer packing list on 7/10/2013.

Device

Device Recall BD Microtainer Quikheel Lancet
  • Model / Serial
    REF # 368101   Lot #3116007  Class I Exempt  Device listing Number E158602
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the states of CT, KY, IL, NY, PA, TX, and VA and the country of Canada.
  • Product Description
    BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lakes, NJ 07417 USA Made in USA. || Used to perform heel sticks for the purpose of collecting skin puncture blood.
  • 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