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Insulet Corporation recalls OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management
Recalled December 23, 2015 · FDA recall Z-0393-2016 · 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
26,230.9 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 (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.
Manufacturer(s)
Insulet Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →