BEUDAMED
    FDA Recall Terminated

    ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide

    Recall: Z-0229-04 · Initiated November 18, 2003

    Recall

    Recall Number
    Z-0229-04
    Event Number
    27748
    Firm
    Alcon Laboratories, Inc
    FEI Number
    1610287
    Product Code
    LPO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 18, 2003
    Posted
    December 17, 2003
    Terminated
    October 20, 2004
    Address
    6600 South Fwy Fort, Worth, TX, 76134-2901

    Description

    ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide

    Reason

    The firm initiated the recall on 11/18/2003 via letters to all consignees. The letter advises physicians to stop using any patient bracelets (blue color) that contain the word 'stickoxid', destroy all blue bracelets, and identify all patients who had either ISPAN gas administered who may still have a bubble present in the eye.

    Action

    The patient bracelet that is given to patients post surgery after administering either ISPAN Perfluoropropane or ISPAN Sulfur Hexafluordie referred to the term, 'stickoxid', which is the general term for nitrogen oxide and may be interpreted as either nitrogen monoxide (NO) or dinitrogen monxoide. The firm is recalling the old (blue) bracelets and replacing them with new (grey) bracelets that now reference the specific term dinitrogen monoxide N20 (laughing gas).

    Distribution

    Germany, Switzerland, and Austria