BEUDAMED
    FDA Enforcement Class II Terminated

    King LTS-D Kit Size 1, Model Number KLTSD431

    Recall: Z-1681-2019 · Reported June 5, 2019

    Enforcement

    Recall Number
    Z-1681-2019
    Event ID
    82036
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    King Systems Corp. dba Ambu, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2019
    Initiation Date
    January 4, 2019
    Classification Date
    May 29, 2019
    Termination Date
    April 20, 2020
    Address
    15011 Herriman Blvd, N/A, Noblesville, IN, 46060-4253, United States

    Description

    King LTS-D Kit Size 1, Model Number KLTSD431

    Reason

    Size 0 products were incorrectly packaged and labeled as a size 1 products.

    Code Info

    Lot code 1000147351

    Distribution

    The products were distributed to the following US states: CA, CT, FL, IA, IN, MD, MS, NC, PA, TX, and WI.

    Quantity

    270