Events

Recall of Becton Dickinson and Company

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
    62394
  • Event Risk Class
    Class 2
  • Event Number
    Z-0564-2013
  • Event Initiated Date
    2012-10-02
  • Event Date Posted
    2012-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110423
  • 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
    Bd received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.
  • Action
    Becton Dickinson sent a Urgent Product Recall letter/Customer Packing list dated October 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to review inventory and determine if they have any of the affected product. If so, it should be removed from inventory. The enclosed customer list should be completed as well. Any questions please call 1-201-847-4267.

Device

Becton Dickinson and Company
  • Model / Serial
    Device Listing Number - R060456  REF Lot # 305217 2076404 305217 2055156 305217 2020057 305217 2020056 305219 1346419
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    (USA) nationwide
  • Product Description
    Case Carton: || BD Oral Dispensing Syringe || 1 mL Clear with Tip Cap || BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com || BD, Laagstraat 57, B-9140 Temse, Belgium || On 100 unit plastic bag: || BD oral syringes are intended to dispense oral medications.
  • 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