Events

Recall of Device Recall Alaris

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

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
    70608
  • Event Risk Class
    Class 2
  • Event Number
    Z-1311-2015
  • Event Initiated Date
    2015-03-12
  • Event Date Posted
    2015-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134153
  • 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
    Carefusion is recalling the alaris pc unit because of an error code. the error code may occur upon power on during the "power-on self test" due to a keypad issue.
  • Action
    CareFusion sent an Urgent: Medical Device Recall Notification letter dated March 12, 2015, to all affected customers. The letter informs the customers that CareFusion has received service reports of a system error on the Alaris PC unit 8015. The letter informs customers of the problems identified and the actions to be taken. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018, supportcenter@carefusion.com. Customers with adverse event reports are instructed to contact customer advocacy at (888) 812-3266, customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris system are instructed to contact technical support at (888) 812-3229, DL-US-INF-TechSupport@carefusion.com.

Device

Device Recall Alaris
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and worldwide to: Canada, Netherlands, New Zealand and Singapore
  • Product Description
    CareFusion Alaris PC Unit Model 8015 (formerly Medley || PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December || 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.
  • Manufacturer
    CareFusion Corporation

Manufacturer

CareFusion Corporation
  • Manufacturer Address
    CareFusion Corporation, 10020 Pacific Mesa Blvd, San Diego CA 92121
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA