Events

Recall of OmniPod Insulin Management System Starter Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Insulet Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66425
  • Event Risk Class
    Class 2
  • Event Number
    Z-0165-2014
  • Event Date Posted
    2013-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122396
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion, insulin - Product Code LZG
  • Reason
    Alcohol prep pads contained within the kit are not properly labeled.
  • Action
    Insulet sent an Important Corrective Action Notification letter dated September 27, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are asked to discontinue use and properly dispose of the affected product. For questions contact Customer Care at (866) 941-0294.

Device

OmniPod Insulin Management System Starter Kit
  • Model / Serial
    Lot Numbers: L13483, L13485, L13478, & L13481
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the country of Israel.
  • Product Description
    OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) || Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Insulin Management System prior to initiating care. It includes the Personal Diabetes Manager (PDM) with two AAA alkaline batteries, a USB cable, a Users Guide, a Soft Carrying Case, a Troubleshooting guide, a Warranty Registration Card, and two Alcohol Pads. The OmniPod 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. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly.
  • Manufacturer
    Insulet Corporation

Manufacturer

Insulet Corporation
  • Manufacturer Address
    Insulet Corporation, 9 Oak Park Drive, Bedford MA 01730-1413
  • Manufacturer Parent Company (2017)
    Insulet Corporation
  • Source
    USFDA