Events

Recall of Device Recall Vacutainer

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
    79041
  • Event Risk Class
    Class 2
  • Event Number
    Z-0968-2018
  • Event Initiated Date
    2017-08-29
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161224
  • 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
    A limited portion of the lot was manufactured with less than the required amount of k2edta additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery.
  • Action
    In August of 2017 All US direct consignees were contacted via e-mail and/or UPS mail. An Urgent Product Removal Recall letter was issued, identifying the affected device and the reason for the recall. It also requested customers to review their inventory and quarantine any affected devices, which will be returned to the firm for replacement. The Customer Recall Response Form should be completed and returned regardless of whether there is any affected devices on hand. For questions or concerns please contact Customer Service at 1-855-215-4992.

Device

Device Recall Vacutainer
  • Model / Serial
    Catalog No. 367841 Lot No. 6279849 UDI: (01)30382903678410
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. || Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
  • 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