BEUDAMED
    FDA Recall Terminated

    Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA

    Recall: Z-0555-2007 · Initiated August 13, 2007

    Recall

    Recall Number
    Z-0555-2007
    Event Number
    39378
    Firm
    Cardinal Health 303 Inc DBA Alaris Products
    FEI Number
    3003879246
    Product Code
    BRY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 13, 2007
    Posted
    September 26, 2007
    Terminated
    March 28, 2012
    Address
    10221 Wateridge Cir, San Diego, CA, 92121-2733

    Description

    Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA

    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.

    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.

    Quantity

    369