BEUDAMED
    FDA Recall Open, Classified

    Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

    Recall: Z-0108-2018 · Initiated September 10, 2017

    Recall

    Recall Number
    Z-0108-2018
    Event Number
    78125
    Firm
    Medtronic Inc.
    FEI Number
    3003166194
    Product Code
    FPA
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    September 10, 2017
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

    Reason

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

    Action

    The firm initiated its recall on 09/11/2017 by issuing a public notice, following with letters and emails. The firm also employed the use of Facebook and Twitter as well as posting on its website. The recall notice directs the customer to visit https://checklots.medtronicdiabetes.com for information on the lot numbers. Persons with additional questions may call Medtronic at 1.888.204.7616.

    Distribution

    Worldwide

    Quantity

    1,898,570 units