Events

Recall of #309604 -- 10 mL syringe

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
    32165
  • Event Risk Class
    Class 2
  • Event Number
    Z-1058-05
  • Event Initiated Date
    2005-05-25
  • Event Date Posted
    2005-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40380
  • 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
    The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
  • Action
    BD contacted their customers via phone and overnight mail letter . End users were notified by overnight mail with confirmation of delivery.

Device

#309604 -- 10 mL syringe
  • Model / Serial
    309604 10 ML Syringe 5074833
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.
  • Product Description
    #309604 -- 10 mL syringe
  • 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