Events

Recall of Device Recall Jadak Barcode Scanner

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CareFusion 303, Inc..

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
    73093
  • Event Risk Class
    Class 2
  • Event Number
    Z-0814-2016
  • Event Initiated Date
    2016-01-15
  • Event Date Posted
    2016-02-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143056
  • 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
    Cabinet, table and tray, anesthesia - Product Code BRY
  • Reason
    Customers reported issues when scanning medications with the scanners. when a user scans a medication using the affected barcode scanner, information on a different medication could be communicated to the pyxis product.
  • Action
    BD sent an Urgent Medical Device Recall Notification letter dated January 15, 2015 to all affected customers The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete the enclosed Customer Response Card by selecting the desired deployment option and return the card to CareFusion. Customers with questions are instructed to contact the CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact CareFusion Customer Advocacy at (800) 836-7842. Customers with technical questions are instructed to contact CareFusion Technical Support at (800) 727-6102.

Device

Device Recall Jadak Barcode Scanner
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide:Distribution - US Nationwide and the countries of Saudi Arabia, Bahrain, Australia, United Arab Emirates, Qatar, Mexico, Guam and the Bahamas.
  • Product Description
    Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. || Product Usage: || An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients.
  • Manufacturer
    CareFusion 303, Inc.

Manufacturer

CareFusion 303, Inc.
  • Manufacturer Address
    CareFusion 303, Inc., 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA