Events

Recall of Device Recall BD Vacutainer Multiple Sample and Direct Draw Luer Adapter

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
    65322
  • Event Risk Class
    Class 2
  • Event Number
    Z-1923-2013
  • Event Initiated Date
    2013-05-01
  • Event Date Posted
    2013-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118556
  • 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 vacutainer multiple sample and direct draw luer adapter may have blood leakage and low draw volume.
  • Action
    BD sent a Product Advisory Notice dated May 3, 2013, via UPS to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discard filled tubes since it is possible they will contain less blood volume (low draws), replace the Luer Adaptor unit being used with a fresh unit, and continue to draw blood samples using the fresh unit. Customers with questions were instructed to contact BD Technical Service at 1-800-631-0174, Option 4, or contact them through website: www.bd.com/vacutainer/contact. For questions regarding this recall call 201-847-6800.

Device

Device Recall BD Vacutainer Multiple Sample and Direct Draw Luer Adapter
  • Model / Serial
    Marketing Status: Class II, 510K # K991088 Device Listing Number: D030347  Catalog number 367290, 367300 (CE), 368491, and 303380.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    BD Vacutainer Multiple Sample and Direct Draw Luer Adapter || BD Franklin Lakes, NJ 07417 USA || A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.
  • 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