BEUDAMED
    FDA Enforcement Class III Terminated

    LUNA Chest, Model No. LU4006

    Recall: Z-0469-2015 · Reported December 3, 2014

    Enforcement

    Recall Number
    Z-0469-2015
    Event ID
    69839
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Novadaq Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 3, 2014
    Initiation Date
    November 4, 2014
    Classification Date
    November 26, 2014
    Termination Date
    November 6, 2015
    Address
    13155 Delf Place, N/A, Richmond, British Columbia, N/A, Canada

    Description

    LUNA Chest, Model No. LU4006

    Reason

    Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.

    Code Info

    Kit Lot Numbers: 13116, 14012, 14017, 14056, 14074, 14103, 14107 Drape Lot Numbers: D132172, D132602, D162692, D132602, D132712, D141002, D130282

    Distribution

    Nationwide Distribution to IA, LA, GA, MD, ID, FL, TN, OH, TX, NC, MA, KY, KS, WI, IN, SC, OR, CT, CA, WA, PA, OK, and PR.

    Quantity

    828 units