BEUDAMED
    FDA Recall Terminated

    Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1

    Recall: Z-0347-2020 · Initiated December 18, 2018

    Recall

    Recall Number
    Z-0347-2020
    Event Number
    82003
    Firm
    Insulet Corporation
    FEI Number
    3004464228
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 18, 2018
    Terminated
    May 13, 2020
    Address
    600 Technology Park Dr, Ste 200, Billerica, MA, 01821-4150

    Description

    Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1

    Reason

    There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.

    Action

    Urgent Medical Device Correction letters dated 12/18/18 were sent to customers.

    Distribution

    US Nationwide.

    Quantity

    264