FDAClass IIIMarch 1, 2017

Daavlin Aquex recall

Daavlin Aquex (DAAV1000)

Why was Daavlin Aquex recalled?

The device was reclassified from a class III device to a class II device and there are new documentation requirements.

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?

SN# 16-3.8001 to 16-3.8250

Product
Daavlin Aquex (DAAV1000)
Recalling firm
Hidrex GmbH
Quantity
250 units
Distribution
Nationwide throughout the US
Recall date
March 1, 2017
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls