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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Event Detail

Event ID 66425
Product Type Devices
Status Ongoing
Recalling Firm Insulet Corporation
City Bedford
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-27
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA Nationwide and the country of Israel.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot Numbers: L13483, L13485, L13478, & L13481 Class II Alcohol Prep Pads contained within the kit are not properly labeled. 1,719 starter kits Z-0165-2014
OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase. Each Demonstration Kit includes a UST400 brochure, one Alcohol Pad, and a Pod. 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. Lot Numbers: L13470 Class II Alcohol Prep Pads contained within the kit are not properly labeled. 5,050 kits Z-0166-2014
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