BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)

    Recall: Z-0111-2018 · Reported November 29, 2017

    Enforcement

    Recall Number
    Z-0111-2018
    Event ID
    78125
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Press Release
    Report Date
    November 29, 2017
    Initiation Date
    September 10, 2017
    Classification Date
    November 18, 2017
    Address
    18000 Devonshire St, N/A, Northridge, CA, 91325-1219, United States

    Description

    Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)

    Reason

    Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

    Code Info

    Lot Numbers: 6211649, 6207537

    Distribution

    Worldwide

    Quantity

    5,842 units