Insulet Corporation: Medical Device Recall in 2013 - (Recall #: Z-0165-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: September 27, 2013

Date Posted: November 13, 2013

Recall Number: Z-0165-2014

Event ID: 66425

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,719 starter kits

Code Information:

Lot Numbers: L13483, L13485, L13478, & L13481

Distribution Pattern:

Worldwide Distribution - USA Nationwide and the country of Israel.

Voluntary or Mandated:

Voluntary: Firm initiated