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U.S. Department of Health and Human Services

Class 2 Device Recall OmniPod Insulin Management System Starter Kit

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 Class 2 Device Recall OmniPod Insulin Management System Starter Kitsee related information
Date Initiated by FirmSeptember 27, 2013
Date PostedNovember 05, 2013
Recall Status1 Terminated 3 on March 04, 2014
Recall NumberZ-0165-2014
Recall Event ID 66425
510(K)NumberK122953 
Product Classification Pump, infusion, insulin - Product Code LZG
ProductOmniPod 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.
Code Information Lot Numbers: L13483, L13485, L13478, & L13481
Recalling Firm/
Manufacturer		 Insulet Corporation
9 Oak Park Drive
Bedford MA 01730-1413
For Additional Information Contact
866-941-0294
Manufacturer Reason
for Recall		Alcohol Prep Pads contained within the kit are not properly labeled.
FDA Determined
Cause 2		Labeling design
ActionInsulet 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.
Quantity in Commerce1,719 starter kits
DistributionWorldwide Distribution - USA Nationwide and the country of Israel.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LZG
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