Events

Recall of Device Recall SmartSite Low Sorbing Infusion 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
    66150
  • Event Risk Class
    Class 2
  • Event Number
    Z-2279-2013
  • Event Initiated Date
    2013-08-30
  • Event Date Posted
    2013-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121570
  • 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
    Carefusion is recalling the smartsite low sorbing infusion set, model 72313e, lot number 13016314, because of an incorrect filter was assembled on this lot. the correct filter is a 1.2 micron filter (blue color) but a 0.2 micron filter (clear color) may have been added instead.
  • Action
    CareFusion sent an Urgent Medical Device Recall Notification dated August 30, 2013, to all affected customers. The letter informed the customers of the problem identified, issues, potential risk, and the immediate actions to be taken. Customers were instructed to immediately check their inventory for the affected product, if any affected product is encountered, customers were instructed not to use. Customers were instructed to complete the customer response form and return the form to CareFusion with the affected product for replacement.. A distributor letter was also sent to distributors on August 30, 2013, to inform them of the problems identified and the actions to be taken. Distributors were instructed to contact the Customer Support Team, return customer response form, and if they have questions then they were instructed to contact the CareFusion Support Center at 1-800-562-6018. For questions regarding this recall call 858-617-4000.

Device

Device Recall SmartSite Low Sorbing Infusion Set
  • Model / Serial
    Lot Number 13016314
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, FL, AZ, and TN
  • Product Description
    SmartSite Low Sorbing Infusion Set, Model#72313E || The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite Low Sorbing set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a 1.2 micron filter, needleless SmartSite connector, low sorbing tubing segment, pinch clamps, and luer connectors.
  • 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