FDAClass IIAugust 20, 2014

Medtronic MiniMed Guardian Monitor recall

Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time…

Why was Medtronic MiniMed Guardian Monitor recalled?

Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue that has the potential to compromise the water resistance of the affected Guardian monitors.

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?

CSS7100 and CSS7100K

Product
Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time…
Recalling firm
Medtronic MiniMed Inc.
Quantity
86 units
Distribution
Worldwide:Distribution - US Nationwide and the countries of Croatia, Denmark, Finland, Germany, Netherlands, Norway, Sweden, Switzerland.
Recall date
August 20, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls