Events

Recall of Device Recall Pyxis

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
    53991
  • Event Risk Class
    Class 2
  • Event Number
    Z-1015-2013
  • Event Initiated Date
    2009-11-20
  • Event Date Posted
    2013-03-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86996
  • 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
    Cabinet, table and tray, anesthesia - Product Code BRY
  • Reason
    The recall was initiated because carefusion has confirmed that when the pas 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.
  • Action
    Carefusion sent a Safety Alert Notification letter dated January 13, 2010 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to ensure back-up procedures were in place in case of system down-time or lock-up, including review of the back-up procedures with staff. The letter included an update to the PAS 2000 User Guide. The letterstates that a CareFusion field representative will be contacting customers to make arrangements to apply warning labels to the PAS 2000 electronics doors. Customers were instructed to complete and return the Response Card included. For questions contact your local field support representative ot the Advocacy department at customer.advocacy@carefusion.com.

Device

Device Recall Pyxis
  • Model / Serial
    All Pyxis Anesthesia System Model 2000
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide) including CANADA.
  • Product Description
    Pyxis Anesthesia System Model 2000 (PAS 2000) || Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.
  • 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