Events

Recall of Device Recall SmartSite Extension Set

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
    67774
  • Event Risk Class
    Class 2
  • Event Number
    Z-1459-2014
  • Event Initiated Date
    2014-03-19
  • Event Date Posted
    2014-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126255
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    Disconnections and leakages at the connection of the smallbore tubing and the smartsite y-port.
  • Action
    CareFusion sent an Urgent Medical Device Recall Notification letter dated March 2014 to all customers. The letter informs the customers of the problems identified, potential risk and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclosed recall response card. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266 or email customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3299.

Device

Device Recall SmartSite Extension Set
  • Model / Serial
    Lot No. 13085791
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution in the states of: AR, AZ, CA, CO, FL, ID, MD, MI, NC, NV, OK, OR, PA, TX, VA, WI
  • Product Description
    SmartSite Extension Set, Model No. 20029E, intravascular administration set.
  • 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