Events

Recall of BD Vacutainer Blood Transfer Device. It consists of a Luer attached via a hub to a needle covered with a sleeve.

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
    32808
  • Event Risk Class
    Class 2
  • Event Number
    Z-1423-05
  • Event Initiated Date
    2005-07-11
  • Event Date Posted
    2005-08-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40854
  • 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
    Customer complaints state the needle had separated from the hub, resulting in blood exposure and/or dislocation of the needle.
  • Action
    A customer communication was sent by first class mail on 7/26/05, advising all consignees of the problem. The letter asks each customer to immediately examine their inventory for affected lot numbers, return product from affected lots using enclosed label and packing slip, and to notify all of their affected customers to alert them to the situation.

Device

BD Vacutainer Blood Transfer Device. It consists of a Luer attached via a hub to a needle covere...
  • Model / Serial
    Catalog #364880, Lot #5076799, Exp 2/2008; #50076797, exp. 2/2008; #5976798, Exp 2/2008; #5098260, Exp 3/2008; #5112114, Exp 3/2008.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    BD Vacutainer Blood Transfer Device. It consists of a Luer attached via a hub to a needle covered with a sleeve.
  • 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