Events

Recall of Device Recall BD

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
    70079
  • Event Risk Class
    Class 2
  • Event Number
    Z-1055-2015
  • Event Initiated Date
    2014-12-19
  • Event Date Posted
    2015-02-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132220
  • 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 stopper of the 10ml bd luer-lok syringe is not properly seated in the syringe.
  • Action
    BD sent an Urgent Product Advisory Notice letter dated 12/19/2014. The letter identified the affected product, problem and actions to be taken. Customers are advised of the issue with the product and should notify their customers. The attached Product Advisory Response Form should be completed and faxed to 1-866-551-2707. Questions can be directed to 1-866-367-4703.

Device

Device Recall BD
  • Model / Serial
    Catalog #303348, Lot #4209518  Catalog #305064, Lot #4205576  Catalog #309644 Lot #4209524
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, || BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 || BD 10 mL Syringe Luer-Lok Tip with BD Precision Glide Needle 20G x 1 (0.9mm x 25mm); Catalog #305064 || Product Usage: || 1) BD Blunt Plastic Cannula is used to penetrate pre-slit septums covering injection sites, as well as vials designed for penetration with needless IV access cannula. || 2) The blunt steel canula will be targeted for exiting applications of pointer cannula, where blunt steel cannula would provide increased safety. Such existing applications include: || -Accessing pre-slit/pre-pierced IV septum ports || -Providing for fluid transfer || -Can be used as tubing adapter || 3) The BD single use Hypodermic Syringe is intended for use by healthcare professional for general purpose fluid aspiration/injection.
  • 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