Events

Recall of Device Recall BD 60ml Syringe LuerLok tip

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
    52601
  • Event Risk Class
    Class 2
  • Event Number
    Z-1811-2009
  • Event Initiated Date
    2009-07-07
  • Event Date Posted
    2009-08-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83442
  • 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
    Syringe, piston - Product Code FMF
  • Reason
    Insufficient seal: becton dickinson received complaints of insufficient/open seals on one lot of 60 ml luer-lok syringes.
  • Action
    Becton Dickinson issued an "Urgent: Product Recall" notice via UPS tracking dated July 7, 2009 to all distributors informing them of the affected product. The firm asked all distributors to identify end customers in an attempt to notify all customers. The firms asks that all affected product be returned. Further questions should be directed to BD Customer Service representatives at 1-888-237-2762.

Device

Device Recall BD 60ml Syringe LuerLok tip
  • Model / Serial
    Product Number: 309653; Lot Number: 819101A.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- Including states of IL, CA, VA, PA, and FL.
  • Product Description
    BD 60ml Syringe Luer-Lok tip, Sterile, BD, Franklin Lakes, NJ 07417, Made in USA.
  • 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