Events

Recall of Pyrxis Anesthesia System 3500

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardinal Health 303 Inc DBA Alaris Products.

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
    39378
  • Event Risk Class
    Class 2
  • Event Number
    Z-0555-2007
  • Event Initiated Date
    2007-08-13
  • Event Date Posted
    2007-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55350
  • 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
    ANESTHESIA MEDICATION STATION - Product Code BRY
  • Reason
    System lock up; mini-drawers -under certain circumstances during use, are not accessable, delaying the user from accessing critical medications.
  • Action
    The field action consisted of phone calls and a mailing conducted to all customers for the Pyxis Anesthesia System 3500 beginning on 08/13/2007. The customers will be notified by registered return receipt mail by Recall Notifications dated August 14, 2007. Separate letters will be sent to the Director of Pharmacy, Chief of Anesthesia, Director of Risk Management, and Director of Surgery at each facility. Recommended actions will be provided as a short-term fix and a long-term fix of the software will be issued shortly.

Device

Pyrxis Anesthesia System 3500
  • Model / Serial
    All serial numbers of the Pyxis Anesthesia Station, Model 3500
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide to Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Missouri, Mississippi, Montana, New Jersey, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, and Wyoming.
  • Product Description
    Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA
  • Manufacturer
    Cardinal Health 303 Inc DBA Alaris Products

Manufacturer

Cardinal Health 303 Inc DBA Alaris Products
  • Manufacturer Address
    Cardinal Health 303 Inc DBA Alaris Products, 10221 Wateridge Cir, San Diego CA 92121-2733
  • Source
    USFDA