Insulet Corporation: 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.

Recall number

Z-0166-2014

Recalling firm

Insulet Corporation

Product

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.

Status

Terminated

Initiated

2013-09-27

Posted

2013-11-05

Terminated

2014-03-04

Reason

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

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

5,050 kits

Distribution

Worldwide Distribution - USA Nationwide and the country of Israel.

Lot, serial or model codes

Lot Numbers: L13470

510(k) numbers

["K122953"]

PMA numbers

not on file

Product code

LZG

Firm FEI

3004464228

Firm city

Bedford

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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