Events

Recall of Device Recall BD 30ml Syringe Luer Lok 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
    53901
  • Event Risk Class
    Class 2
  • Event Number
    Z-0586-2010
  • Event Initiated Date
    2009-11-23
  • Event Date Posted
    2009-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86845
  • 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
    Reports received of open seals on lot # 9175046, bd 30 ml luer-lok syringes. this indicates product sterility may be compromised.
  • Action
    Recall notification letters were sent to all distributors on 11/23/2009 by Federal Express. BD called all distributors to get customer lists and will start sending letter to customers commencing on December 8, 2009. Questions are directed to BD Customer Service at 1-888-237-2762, Monday  Friday, 8:00 AM  5:00 PM Eastern Time.

Device

Device Recall BD 30ml Syringe Luer Lok Tip
  • Model / Serial
    Catalog Number: 309650; Lot number 9175046
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributors nationwide.
  • Product Description
    BD 30 ml Syringe; || Luer-Lok Tip || Catalog # 309650 || Becton Dickinson, Franklin Lakes, NJ.
  • 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