FDAFDA · Food and drugs·Recall number Z-0394-2016
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 quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
Published December 23, 2015 · Recall initiated: November 2, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Insulet Corporation
- Distributor
- Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
- Lot
- Lot Codes: L41908, L41910, F41935
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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