FDAClass IIIMarch 1, 2017

Hidrex USA DP450 recall

Hidrex USA DP450

Why was Hidrex USA DP450 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# 16-3.7091 to 16-3.7134, 17-3.7001 to 17-3.7020

Product
Hidrex USA DP450
Recalling firm
Hidrex GmbH
Quantity
64 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