BEUDAMED
    FDA Enforcement Class II Terminated

    Ventilator Tubing

    Recall: Z-0269-2016 · Reported November 18, 2015

    Enforcement

    Recall Number
    Z-0269-2016
    Event ID
    72396
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instrumentation Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 18, 2015
    Initiation Date
    September 23, 2015
    Classification Date
    November 12, 2015
    Termination Date
    November 28, 2016
    Address
    2990 Industrial Blvd, N/A, Bethel Park, PA, 15102-2536, United States

    Description

    Ventilator Tubing

    Reason

    As a distributor of tubing manufactured by Smooth Bore Plastics, we are initiating a product recall for specific lots of KC 036, KC 060 and KC 072 reusable ventilator tubes due to a possible manufacturing defect: A few tubes may have the potential for delamination to occur between the layers of the tube wall which, should it occur, would result in leakage

    Code Info

    Model Length Lot Numbers KC 036 36 tube P0614015, P0818215, P0825515 KC 060 60 tube P0511915, P0608315 KC 072 72 tube P0618415, P0818515

    Distribution

    Worldwide Distribution - US including PA, FL, GA, WA, OH, CA, KA and Internationally to Canada.

    Quantity

    567