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
    56257
  • Event Risk Class
    Class 1
  • Event Number
    Z-0006-2011
  • Event Initiated Date
    2010-07-13
  • Event Date Posted
    2010-10-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93083
  • 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
    infusion pump and monitor - Product Code FRN
  • Reason
    Under certain wireless network conditions a communication error can occur, which freezes the pc unit screen, which may result in a delay of therapy. a delay of therapy may result in serious injury and/or death. carefusion identified this potential risk associated with the alaris pc unit model 8015 only (pc unit) manufactured between december-2008 and september-2009.
  • Action
    CareFusion sent the customer notification letter to all customers using the affected Alaris PC Unit beginning August 24, 2010. The customer notification letter is addressed to the Directors of Nursing, Risk Management, and Biomedical Engineering. Customers will be 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 recall notice informed the customers of the reason for the notice, the units affected, the potential risk, a step-by-step description of the issue and the required actions for users. The customers were also told that CareFusion will contact their facility through phone or in person within 60 days to initiate implementation of the corrective action. The corrective action will require a hardware update to all affected units. CareFusion does not require that you return your devices. In the interim, if you observe this issue, remove the device from service and contact CareFusion Recall Center immediately. Customers were also told that any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program. The recall notice provided contact information for CareFusion's Recall Center, Customer Advocacy and Technical Support units.

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