BEUDAMED
    FDA Recall Terminated

    King LTS-D Kit Size 1, Model Number KLTSD431

    Recall: Z-1681-2019 · Initiated January 4, 2019

    Recall

    Recall Number
    Z-1681-2019
    Event Number
    82036
    Firm
    King Systems Corp. dba Ambu, Inc.
    FEI Number
    1824226
    Product Code
    CAE
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    January 4, 2019
    Terminated
    April 20, 2020
    Address
    15011 Herriman Blvd, Noblesville, IN, 46060-4253

    Description

    King LTS-D Kit Size 1, Model Number KLTSD431

    Reason

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

    Action

    Urgent Medical Device Recall notification letters were sent to customers beginning 1/4/19.

    Distribution

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

    Quantity

    270