BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)

    Recall: Z-0109-2018 · Reported November 29, 2017

    Enforcement

    Recall Number
    Z-0109-2018
    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) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)

    Reason

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

    Code Info

    Lot Numbers: 5188321 5190185 5190186 5184968 5185467 5185468 5185469 5185470 5188322 5188323 5188324 5188325 5188326 5188327 5188328 5189476 5189477 5189478 5189521 5189522 5190187 5190188 5190189 5191046 5191047 5191355 5192532 5183060 5183061 5187300 5187301 5187556 5187557 5189051 5193052 5188329 5188330 5189053 5189054 5194937 5185690 5187558 5191357 5187559

    Distribution

    Worldwide

    Quantity

    2,163,610 units