BEUDAMED
    FDA Enforcement Class II Terminated

    MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.

    Recall: Z-2260-2015 · Reported August 5, 2015

    Enforcement

    Recall Number
    Z-2260-2015
    Event ID
    70897
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic MiniMed Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 5, 2015
    Initiation Date
    June 19, 2015
    Classification Date
    July 24, 2015
    Termination Date
    October 2, 2015
    Address
    18000 Devonshire St, N/A, Northridge, CA, 91325-1219, United States

    Description

    MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.

    Reason

    Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios where the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate.

    Code Info

    n/a

    Distribution

    Australia, Czech Republic, Denmark, Finland, France, Ireland, Netherlands, Norway, Sweden, United Kingdom.

    Quantity

    1936 units