Events

Recall of BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing

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
    75252
  • Event Risk Class
    Class 2
  • Event Number
    Z-0745-2017
  • Event Initiated Date
    2016-08-08
  • 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=149793
  • 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 has received multiple reports of units associated with the 23 g x .75 in. bd vacutainer¿ push button blood collection set with 12 in. tubing whose lots are exhibiting separation of front and rear barrels upon activation of the safety feature, which retracts the needle.
  • Action
    The firm, BD, sent a "URGENT PRODUCT RECALL" letter dated 8/8/2016 to its customer with a return response form via UPS 2nd Day mail on 8/8/2016.The letter described the product, problem and actions to be taken. The customers were instructed to immediately review your inventory for the specific lot numbers, quarantine the product and discontinue the shipment of the affected product; complete and return the Recall Response Form by fax to BD at 1-866-913-0661 or email to bd6835@stericycle.com (even if you do not have any product); return all affected products with completed response form per packing instructions; if you have distributed this product, identify your customers and notify them immediately of this product recall; if you would like BD to conduct the notification to your customers, email your customer list within 3 business days to Matthew.Kelleher@bd.com. if you have any questions or require assistance with the return of the recalled product and/or availability of credit product, contact 1-888-628-0732 between 8Am and 5 PM ET Monday through Friday.

Device

BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing
  • Model / Serial
    5355531 5355533 5356681 5356682 6006629 6006630 6006631 6006633 6006634 6006650
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution- US (nationwide) and countries of: Canada, Belgium, Brazil.
  • Product Description
    BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood || Collection Set with 12 in. Tubing || Catalog # 367342 || Intended for venipuncture to obtain blood specimens from 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