FDA-Device2015-12-23Class I
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.
Insulet Corporation
Hazard
Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
Sold states
Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
Affected count
26,230.9 boxes
Manufactured in
600 Technology Park Dr Ste 200, N/A, Billerica, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0393-2016Don't want to check this manually?
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