BEUDAMED
    FDA Recall Terminated

    OmniPod, Insulin Management System (OUS) Catalog Number: 14810 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-0394-2016 · Initiated November 2, 2015

    Recall

    Recall Number
    Z-0394-2016
    Event Number
    72535
    Firm
    Insulet Corporation
    FEI Number
    3004464228
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    November 2, 2015
    Posted
    December 15, 2015
    Terminated
    March 7, 2017
    Address
    600 Technology Park Dr, Ste 200, Billerica, MA, 01821-4126

    Description

    OmniPod, Insulin Management System (OUS) Catalog Number: 14810 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.

    Action

    Insulet issued on 11/2/15 an URGENT: Field Safety Notification via Email notification and Federal Express. Letter describes the problem that certain lots of the pod's needle failed to deploy or there is a delay in the deployment of the needle. Customers not responding to the email or Federal Express will receive additional mailing and/or follow up phone calls. Call Customer Care at 1-855-407-3729 if you have any questions regarding this Field Safety Notification.

    Distribution

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

    Quantity

    5,179.0 boxes