BEUDAMED
    FDA Enforcement Class II Terminated

    STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box. Some of the pouches inside of cardboard box are incorrectly labeled as Catalog number 20400162S, High Flow Insufflation Tubing (with filter) For 26432020-1 THERMOFLATOR. The firm name on the label is Karl Storz Endoscopy-America, Inc., El Segundo, CA.

    Recall: Z-0098-2018 · Reported November 22, 2017

    Enforcement

    Recall Number
    Z-0098-2018
    Event ID
    78289
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Karl Storz Endoscopy
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 22, 2017
    Initiation Date
    October 10, 2017
    Classification Date
    November 16, 2017
    Termination Date
    June 22, 2018
    Address
    2151 E Grand Ave, N/A, El Segundo, CA, 90245-5017, United States

    Description

    STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box. Some of the pouches inside of cardboard box are incorrectly labeled as Catalog number 20400162S, High Flow Insufflation Tubing (with filter) For 26432020-1 THERMOFLATOR. The firm name on the label is Karl Storz Endoscopy-America, Inc., El Segundo, CA.

    Reason

    The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product.

    Code Info

    Lot #129241

    Distribution

    Distribution was made nationwide. There was government distribution and no military distribution. Foreign distribution was made to Canada.

    Quantity

    496/10-pouch boxes