Events

Recall of Device Recall BD Microtainer MAP Microtube for Automated Process.

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
    59684
  • Event Risk Class
    Class 3
  • Event Number
    Z-0176-2012
  • Event Initiated Date
    2011-02-11
  • Event Date Posted
    2011-11-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103725
  • 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
    Tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • Reason
    Bd microtainer map microtube is being recalled due to the potential clotting of blood specimens resulting from a reduced amount of edta additive.
  • Action
    A Becton Dickinson Sales Consultant conducted a "on-site" visit to the single Customer account, Florida Hospital, on February 11, 2011. All units were successfully recovered. All product recovered was quarantined and destroyed. Becton Dickinson believes that all reasonable efforts to communicate the issue to the affected consignee have been completed. If you have any questions or request additional information please do not hesitate to call (201) 847-5636.

Device

Device Recall BD Microtainer MAP Microtube for Automated Process.
  • Model / Serial
    Lot # 1018904 Catalog # 363706
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only to Florida.
  • Product Description
    BD Microtainer MAP Microtube for Automated Process with K2EDTA. || For the collection, transport, and automated processing of skin punctures samples from infants, children, geriatric, oncology, and critical care patients.
  • 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