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[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 diabe

recall fda device united-states

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductOmniPod¿, 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 meas
Brand / manufacturerInsulet Corporation
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0393-2016
Country of noticeUnited States
Risk levelClass I
Hazard typerecall
Notice date02 November 2015

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.

This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from Insulet Corporation

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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