Events

Recall of Device Recall BD Direct Draw Adapters

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
    35831
  • Event Risk Class
    Class 2
  • Event Number
    Z-1463-06
  • Event Initiated Date
    2006-06-21
  • Event Date Posted
    2006-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47289
  • 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
    Direct Draw Adapters - Product Code KSR
  • Reason
    Firm received complaints indicating failure of the non-patient (np) sleeve to function properly. this sleeve covers the cannula and prevents leakage during blood collection.
  • Action
    BD sent out recall notifications on 6/21/2006 to distributors and their direct account customers.

Device

Device Recall BD Direct Draw Adapters
  • Model / Serial
    Catalog Number 364896, Lot Numbers 5311376, 5312193, 5312201.--For European distribution, the products are shipped to Temse located in Belgium who handles the recall. Temse has been identified as recalling only the following products and lots: Catalog Number 364896 (Direct Draw Adapter), lots 5311376, 5312193, 5312201. Catalog Number 367300 (Luer Adapter), lots 5307894, 5307896, 5307900.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide-Products are distributed nationwide to distributors and direct accounts. The products are also distributed internationally to the following locations: Japan, Australia, Canada, Hong Kong, New Zealand. For European distribution, the products are shipped to Temse located in Belgium who handles the recall. Temse has been identified as recalling only the following products and lots: Catalog Number 364896 (Direct Draw Adapter), lots 5311376, 5312193, 5312201. Catalog Number 367300 (Luer Adapter), lots 5307894, 5307896, 5307900. Government accounts include the VAMC in Erie, PA;
  • Product Description
    BD Direct Draw Adapters, Catalog Number 364896.
  • 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