BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0347-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0347-2020
    Event ID
    82003
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Insulet Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2019
    Initiation Date
    December 18, 2018
    Classification Date
    November 7, 2019
    Termination Date
    May 13, 2020
    Address
    600 Technology Park Dr Ste 200, N/A, Billerica, MA, 01821-4150, United States

    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.

    Code Info

    Lot Numbers L000120, L000121, L000122, L000123, L000124, L000131, L000132, L000133, L000135, L000136

    Distribution

    US Nationwide.

    Quantity

    264