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Terminated

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.

FDA Recall Z-0165-2014 · Posted 2013-11-05

Recalling FirmInsulet Corporation
Recall StatusTerminated
Product CodeLZG
Date Initiated2013-09-27
Date Terminated2014-03-04
Product Quantity1,719 starter kits

Reason for Recall

Alcohol Prep Pads contained within the kit are not properly labeled.

Firm 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.

Root Cause

Labeling design

Distribution Pattern

Worldwide Distribution - USA Nationwide and the country of Israel.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122953OMNIPOD INSULIN MANAGMENT SYSTEMInsulet Corporation · 2012-12-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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