Events

Recall of Device Recall SmartSite Low Sorbing Infusion Sets

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
    66759
  • Event Risk Class
    Class 2
  • Event Number
    Z-0450-2014
  • Event Initiated Date
    2013-11-08
  • Event Date Posted
    2013-12-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123304
  • 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 with texium closed male luer because it is not assembled with low-sorbing tubing.
  • Action
    The firm, CareFusion, sent an "URGENT: Medical Device Recall Notification" letter dated November 8, 2013 to all customers who purchased the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to immediately complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card and return all recalled product directly to the distributor form whom it was purchased. Customers with questions are instructed to contact their distributor directly or call the CareFusion Support Center at (888) 562-6018. If you have recall related questions or need support, please call CareFusion Support Center at 1-888-562-6018; hours: 7am to 4pm PST or Technical Support at 1-888-812-3229; hours 7am to 5pm PST.

Device

Device Recall SmartSite Low Sorbing Infusion Sets
  • Model / Serial
    Lot No:  13046215 13046641 13056285 13056577 13075931
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution in CA, WY, OH, UT, and MA.
  • Product Description
    SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T || The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
  • 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