Events

Recall of Device Recall BD 10 ml 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
    46347
  • Event Risk Class
    Class 2
  • Event Number
    Z-0915-2008
  • Event Initiated Date
    2008-01-07
  • Event Date Posted
    2008-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67218
  • 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
    Piston syringe - Product Code FMF
  • Reason
    Defective seal: the convenience trays may have open seals, which can adversely impact tray sterility.
  • Action
    BD notified distributors by an Urgent Product Recall Letter sent via UPS on January 7, 2008. In addition, the firm sent an Urgent Product Recall Letter on January 11, 2008 to customers identified by the distributors. The letter instructed the users to remove the product from its inventory and to return affected products to the firm using an enclosed customer packing list. For additional information, contact 1-888-237-2762.

Device

Device Recall BD 10 ml Syringe Luer Lok Tip
  • Model / Serial
    Reorder number: 3039605; Lot numbers 7061015, 7061014, 7092726, 7094789, 7094790, 7123223, 7123225, 7150947, 7150949, 7184442, 7184443, 7184446, 7212935, 7239568, 7239570, 7239569, 7271873.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including the states of CA, NY, MO, MA, IL, OH, TN, TX, MI, LA, MO, ID, GA, NE, SC and FL.
  • Product Description
    BD 10 ml Syringe Luer Lok Tip, Reorder #3039605, BD, Franklin Lakes, NJ 07417.
  • 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