The Recall Desk

FDA (Devices) recall action 72535

Insulet Corporation recalled 2 products on 2015-12-23

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-12-23
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • SevereFDA (Devices)··2015-12-23

    Insulet Recalls OmniPod Insulin Systems Due to Needle Deployment Failure

    Insulet Corporation is recalling OmniPod Insulin Management Systems because the needle mechanism may fail to deploy or deploy with a delay.

    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 t
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2015-12-23

    Insulet Recalls OmniPod Insulin Management System Due to Needle Deployment Failure

    Insulet Corporation is recalling 5,179 boxes of OmniPod Insulin Management Systems because the needle mechanism may fail to deploy or deploy with a delay.

    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
    Category
    Distribution
    0 states