Events

Recall of Device Recall Alaris PC unit, Model 8015

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
    73631
  • Event Risk Class
    Class 2
  • Event Number
    Z-1606-2016
  • Event Initiated Date
    2016-03-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144638
  • 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 alaris pc units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (c245) at power up on the alaris pc unit logic boards.
  • Action
    The firm, Carefusion, sent a "Medical Device Recall Notification" letter dated March 30, 2016 to its customers. The letter described the product, problem, the potential risk involved and the required action for users. The customers were instructed to do the following: If you observe System Error code 133.6080, remove the PC unit from use and contact the CareFusion Support Center, and promptly complete and return the enclosed Customer Response Card. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018 from 7am-4pm PST, M-F, or by email at supportcenter@carefusion.com. Customers with clinical inquiries, product complaints, or clinical troubleshooting are instructed to contact Customer Advocacy at (888) 812-3266, 24 hrs/day, 7 days/week or by email at customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3229, 6am-5pm PST, M-F or by email at dl-us-inf-techsupport@carefusion.com.

Device

Device Recall Alaris PC unit, Model 8015
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Australia, Great Britain and Canada.
  • Product Description
    Alaris PC unit, Model 8015 || The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
  • 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