BEUDAMED
    FDA Recall 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 · Initiated July 13, 2015

    Recall

    Recall Number
    Z-2485-2015
    Event Number
    71651
    Firm
    Insulet Corporation
    FEI Number
    3004464228
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 13, 2015
    Posted
    September 4, 2015
    Terminated
    January 26, 2017
    Address
    600 Technology Park Dr, Ste 200, Billerica, MA, 01821-4126

    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

    Action

    The firm, Insulet Corporation, sent an "URGENT: Voluntary Device Recall" letter dated 7/13/2015 to each consignee/customer via Email notification (where possible) on 7/13/15 as well as Federal Express. Customers not responding to the email or Federal Express will receive follow up phone calls. The letter described the product, problem and actions to e taken. The customers were instructed to do the following: If you have Pods from any of these lots, set them aside, we will replace them at no charge; arrange for return and replacement by choosing one of the following methods: 1. Complete the online form at https://www.myomnipod.com/podinfo (fastest method). 2. Return the enclosed reply card by mail or fax to 1-855-407-3729. 3. Contact Insulet Customer Care by calling 1-855-407-3729 (any time day or night). If you do not have any unused Pods form these lots, reply using one of the methods above. If you have any question, contact Acting VP RA/QA at 978-600-7000. EXPANDED RECALL: Insulet Corp. issued on 11/2/15 the URGENT: Field Safety Notification via Email notification and Federal Express. Letter describes problem of 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 country of: Switzerland.

    Quantity

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