BEUDAMED
    FDA Enforcement Class II Terminated

    CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.

    Recall: Z-2276-2012 · Reported September 5, 2012

    Enforcement

    Recall Number
    Z-2276-2012
    Event ID
    62919
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advanced Sterilization Products
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2012
    Initiation Date
    June 1, 2012
    Classification Date
    August 27, 2012
    Termination Date
    September 11, 2013
    Address
    33 Technology Dr, N/A, Irvine, CA, 92618-2346, United States

    Description

    CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.

    Reason

    The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on bottles of CIDEX OPA Solution, Part # 20390 manufactured between May 2011 and April 2012.

    Code Info

    Product codes: 20390 (US).

    Distribution

    Nationwide (USA) and Puerto Rico.

    Quantity

    1,310,844 units