FDAClass IINovember 13, 2013

OmniPod Insulin Management System Starter Kit recall

OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: The Starter Kit (SKT-UST400) is…

Why was OmniPod Insulin Management System Starter Kit recalled?

Alcohol Prep Pads contained within the kit are not properly labeled.

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 Numbers: L13483, L13485, L13478, & L13481

Product
OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: The Starter Kit (SKT-UST400) is…
Recalling firm
Insulet Corporation
Quantity
1,719 starter kits
Distribution
Worldwide Distribution - USA Nationwide and the country of Israel.
Recall date
November 13, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls