BEUDAMED
    FDA Recall 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 · Initiated December 23, 2016

    Recall

    Recall Number
    Z-1897-2017
    Event Number
    76294
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 23, 2016
    Terminated
    November 9, 2017
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    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.

    Action

    Becton Dickinson (BD) notified their sole customer Medtronic via e-mail on December 26, 2016. BD recommends that Medtronic notify their customers of the situation. For further questions, please call (201) 847-6800.

    Distribution

    US Distribution to the state of : CA

    Quantity

    57,750 units