Insulet Corporation recalls OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management Syst…

Recall date

November 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0393-2016

FDA classification

Class I

Brand / firm

Insulet Corporation

Sold / distributed

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

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 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.