FDAClass IIFebruary 8, 2017

Intact Disposable Wands recall: Sterility Concern

Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to…

Why was Intact Disposable Wands recalled?

Product sterility compromised due to breach of sterile barrier

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?

All lot codes

Product
Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to…
Recalling firm
Medtronic Advanced Energy, LLC
Quantity
275 units
Distribution
Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
Recall date
February 8, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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