BEUDAMED
    FDA Recall Terminated

    Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX PLUS Products''

    Recall: Z-1479-04 · Initiated September 4, 2003

    Recall

    Recall Number
    Z-1479-04
    Event Number
    27676
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    JOJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 4, 2003
    Posted
    September 21, 2004
    Terminated
    January 4, 2005
    Address
    33 Technology Dr, Irvine, CA, 92618-2346

    Description

    Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX PLUS Products''

    Reason

    Performance failure complaints.

    Action

    Firm issued a Safety Alert to inform users to perform a daily Quality Control check of the test strips to ensure that they are working.

    Distribution

    Nationwide, Europe, Latin America, Australia, Canada, and Asia Pacific.

    Quantity

    11797 cases