BEUDAMED
    FDA Enforcement Class II Terminated

    BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS

    Recall: Z-1897-2017 · Reported May 10, 2017

    Enforcement

    Recall Number
    Z-1897-2017
    Event ID
    76294
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 10, 2017
    Initiation Date
    December 23, 2016
    Classification Date
    May 1, 2017
    Termination Date
    November 9, 2017
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS

    Reason

    Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked.

    Code Info

    6203871 30-Jun-19 6203860 30-Jun-19 6207535 30-Jun-19 6211649 31-Jul-19 6207537 30-Jun-19 6211650 31-Jul-19

    Distribution

    US Distribution to the state of : CA

    Quantity

    57,750 units