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
    62007
  • Event Risk Class
    Class 1
  • Event Number
    Z-2076-2012
  • Event Initiated Date
    2012-05-25
  • Event Date Posted
    2012-07-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109684
  • 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 the alaris pc unit model 8015 has a component on the pc unit power supply board that is causing an error code(120.4630) "system error" or "missing battery error" at start up. the error code is accompanied by both an audible alarm and visual error messages on the pc unit screen.
  • Action
    Carefusion sent an Urgent: Medical Device Recall Notification letter dated June 27, 2012 to all their customers who purchased the Alaris PC unit (model 8015). The letter identified the affected units, explanation of the problem, potential risk and actions to be taken. Customers were instructed to not return their devices. If customers observe either of the error messages identified in the letter, then they were instructed to remove the PC unit from use and contact the Carefusion Support Center. Carefusion will contact their facility by phone within 60 days of receiving this notification to schedule a visit to replace their affected power supply board on their PC unit. Customers were instructed to promptly complete and return the enclosed customer response card to expedite the corrective action process. For questions and support contact: CareFusion Support Center at 888-562-6018 for (Recall Related Questions), Customer Advocacy at 800-854-7128, Option 1, Option 1, Option 3 or email customerfeedback@carefusion.com for (Adverse Event Reports), Technical Support at 888-812-3229 for (Technical Questions Regarding the Alaris System).

Device

Device Recall Alaris PC unit
  • Model / Serial
    not available
  • 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 || Product Usage: The device is labeled for prescription use only.
  • 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