BEUDAMED
    FDA Recall 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 · Initiated October 10, 2017

    Recall

    Recall Number
    Z-0098-2018
    Event Number
    78289
    Firm
    Karl Storz Endoscopy
    FEI Number
    3007475226
    Product Code
    NKC
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    October 10, 2017
    Terminated
    June 22, 2018
    Address
    2151 E Grand Ave, El Segundo, CA, 90245-5017

    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.

    Action

    The recalling firm issued letters flagged as 'SAFETY ALERT" dated 10/5/2017 via Federal Express on 10/10/2017.

    Distribution

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

    Quantity

    496/10-pouch boxes