Events

Recall of Device Recall Alaris PC unit

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
    71081
  • Event Risk Class
    Class 2
  • Event Number
    Z-1811-2015
  • Event Initiated Date
    2015-05-13
  • Event Date Posted
    2015-06-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136048
  • 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
    Pump, infusion - Product Code FRN
  • Reason
    An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. an infusion may start that is greater than or less than the hospital established limits for the specific medication.
  • Action
    CareFusion sent an Urgent Medical Device Recall Notification letter dated May 13, 2015 to customers. The letter identified the affected product, problem and the recommended actions to be taken. Customers are informed that CareFusion has released a software upgrade to address this issue. CareFusion will contact all affected customers within 60 days to initiate the scheduling process for the software upgrade installation. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018, 7am-4pm PT, supportcenter@carefusion.com. Customers with adverse event report questions are instructed to contact customer advocacy at (888) 812-3266, 24 hrs/day, 7 days a week, customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3229, 6am-5pm PT, Mon-Fri, dl-us-inf-techsupport@carefusion.com.

Device

Device Recall Alaris PC unit
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Alaris PC unit model 8015, Infusion pump. software version 9.17 || Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
  • 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