Z-0165-2014Class II

OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit)

Name: Z-0165-2014 OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit)
Creator: Insulet Corporation
Published: 2013-09-27
License: https://open.fda.gov/license/

Insulet Corporation / initiated 2013-09-27 / Terminated / root cause: labeling and UDI

FDA source

Insulet Corporation began a recall of OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: The Starter Kit (SKT-UST400) is provided to... on 2013-09-27. FDA classified it as Class II and gives the reason as "Alcohol Prep Pads contained within the kit are not properly labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0165-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-27
Posted: 2013-11-05
Terminated: 2014-03-04
Recalling firm: Insulet Corporation
Product: 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.
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Alcohol Prep Pads contained within the kit are not properly labeled.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
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.
Quantity in commerce: 1,719 starter kits
Distribution: Worldwide Distribution - USA Nationwide and the country of Israel.
Product codes and lots: Lot Numbers: L13483, L13485, L13478, & L13481

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0165-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0165-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-05
Z-0166-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-05

Product code LZG

K122953Class IIOmnipod Insulin Managment SystemInsulet Corporation / cleared 2012-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)