FDAClass IDecember 23, 2015

OmniPod¿ recall

OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous…

Why was OmniPod¿ recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Codes: L41908, L41910, F41935

Product
OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous…
Recalling firm
Insulet Corporation
Quantity
5,179.0 boxes
Distribution
Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
Recall date
December 23, 2015
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls