Insulet Corporation recalls OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management Sy

Recalled December 23, 2015 · FDA recall Z-0394-2016 · Insulet

Hazard

Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. · FDA Class I

Units

5,179.0 boxes

Sold at

Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.

Description

Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.

Product

OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ 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.

Manufacturer(s)

Insulet Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →