BEUDAMED
    FDA Enforcement Class I Terminated

    OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

    Recall: Z-2485-2015 · Reported September 16, 2015

    Enforcement

    Recall Number
    Z-2485-2015
    Event ID
    71651
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Insulet Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 16, 2015
    Initiation Date
    July 13, 2015
    Classification Date
    September 4, 2015
    Termination Date
    January 26, 2017
    Address
    600 Technology Park Dr Ste 200, N/A, Billerica, MA, 01821-4126, United States

    Description

    OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

    Reason

    OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin

    Code Info

    Lot Numbers: L40771, L40892, L40901, L40905, L40997, L41199, L41208 Expanded Recall: Lot Codes: L41908, L41910, F41935

    Distribution

    Worldwide Distribution: US (Nationwide) and country of: Switzerland.

    Quantity

    16,017 boxes. Expanded Recall: 5,179.0 boxes