BEUDAMED
    FDA Enforcement Class I Terminated

    OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.

    Recall: Z-0393-2016 · Reported December 23, 2015

    Enforcement

    Recall Number
    Z-0393-2016
    Event ID
    72535
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Insulet Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 23, 2015
    Initiation Date
    November 2, 2015
    Classification Date
    December 15, 2015
    Termination Date
    March 7, 2017
    Address
    600 Technology Park Dr Ste 200, N/A, Billerica, MA, 01821-4126, United States

    Description

    OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.

    Reason

    Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.

    Code Info

    Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907

    Distribution

    Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.

    Quantity

    26,230.9 boxes