Events

Recall of Device Recall Alaris PC Unit 8015

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
    64653
  • Event Risk Class
    Class 2
  • Event Number
    Z-1112-2013
  • Event Initiated Date
    2013-03-06
  • Event Date Posted
    2013-04-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116720
  • 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
    The recall was initiated because carefusion has identified potential risk associated with bolus programming with the alaris pc unit (model 8015) software version 9.12. automating infusion pump parameter input from either the electronic medical record (emr) or the alaris auto-id module for a continuous infusion with a bolus dose option may result in a loss of information from the guardrails data s.
  • Action
    Carefusion sent an Urgent Medical Device Recall Notification letter dated March 6, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are required to confirm receipt of the notification by returning the Recall response card to Carefusion by postage-paid, self-addressed mail, fax, or email. The letter stated that a Carefusion representatives will contact customers by telephone to schedule field remediation. For questions call Carefusion Support Center at 888-562-6018, Customer Advocacy at 888-812-3266, and/or Technical Support at 888-812-3229.

Device

Device Recall Alaris PC Unit 8015
  • Model / Serial
    not available
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution USA Nationwide and the countries of Australia and Canada.
  • Product Description
    Alaris PC unit model 8015 with software version 9.12 || Product Usage: || The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System
  • Manufacturer
    Carefusion Corporation

Manufacturer

Carefusion Corporation
  • Manufacturer Address
    Carefusion Corporation, 3750 Torrey View Ct, San Diego CA 92130-2622
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA