BEUDAMED
    FDA Enforcement Class II Ongoing

    RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

    Recall: Z-2347-2024 · Reported July 17, 2024

    Enforcement

    Recall Number
    Z-2347-2024
    Event ID
    94775
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 17, 2024
    Initiation Date
    June 3, 2024
    Classification Date
    July 11, 2024
    Address
    920 Winter St Bld 920, N/A, Waltham, MA, 02451-1521, United States

    Description

    RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

    Reason

    An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

    Code Info

    Model Number: RTLR190395 (Refurbished Rental units); UDI/DI: 00840861100958; Serial Numbers: 6K0S-514F, 6K0S-472G, 6K0S-052M, 6K0S-058N, 5K0S-322B, 5K0S-U131.

    Distribution

    Domestic: Nationwide Distribution. International: Canada.

    Quantity

    6 units