BEUDAMED
    FDA Enforcement Class II Terminated

    The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.

    Recall: Z-2089-2021 · Reported July 28, 2021

    Enforcement

    Recall Number
    Z-2089-2021
    Event ID
    87998
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 28, 2021
    Initiation Date
    April 28, 2021
    Classification Date
    July 16, 2021
    Termination Date
    August 8, 2022
    Address
    920 Winter St Bld 950, N/A, Waltham, MA, 02451-1521, United States

    Description

    The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.

    Reason

    Exposed to freezing temperatures due to refrigerated truck malfunctions

    Code Info

    Lot Number: 20SR08069 UDI: (01)00840861100811 20PR08237 UDI: (01)00840861100811

    Distribution

    US Distribution to: TX only

    Quantity

    5 cases