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
    77077
  • Event Risk Class
    Class 2
  • Event Number
    Z-2671-2017
  • Event Initiated Date
    2017-06-12
  • Event Date Posted
    2017-06-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154930
  • 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
    Bd initiated the recall of alaris pc unit model 8015 after the firm identified five scenarios which can result in the occurrence of systems error code 255-16-275 and can potentially result in interrupted infusions.
  • Action
    BD sent an Medical Device Safety Notification Letter dated June 12, 2017 , to customers to inform them that BD is issuing this Safety Notification letter to inform you of reports of customers experiencing a System Error (error code: 255-16-275) with Alaris System PC unit model 8015 that can result in interruption of infusions. Customers are informed of the issue, potential risk, and required actions to be taken by users and by BD. Customers with questions with the safety notification are instructed to call (888) 562-6018 or email supportcenter@carefusion.com. Customers with adverse event reports are instructed to call (888) 812-3266 or email customerfeedback@carefusion.com. Customers with technical questions are instructed to call (888) 812-3229 or email dl-us-inf-techsupport@carefusion.com. For further questions, please call (858) 617-5925.

Device

Device Recall Alaris PC Unit, Model 8015
  • Model / Serial
    Notification will be distributed to all Alaris PC Unit model 8015 customers with software versions greater than 9.12.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and to the countries of : Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.
  • Product Description
    Alaris PC Unit, Model 8015
  • 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