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
    74142
  • Event Risk Class
    Class 2
  • Event Number
    Z-2064-2016
  • Event Initiated Date
    2016-05-12
  • 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=146476
  • 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
    A patient weight can be populated incorrectly under certain conditions when using the restore feature to restore infusions running on the alaris lvp module model 8100 and the alaris syringe module model 8110.
  • Action
    An Urgent Medical Device Recall Letter was sent to customers on 5/31/16 to inform them that BD had identified an issue with the Alaris System PC unit model 8015 with software versions 9.17 and 9.19. Firm has received reports that a patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110. The letter informs the customers of the potential risk and the required action for users. Customers are informed that BD will contact them within 60 days to initiate the scheduling process for the software upgrade installation.

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