Hidrex GmbH recalls Hidrex USA DP450

Recall date

January 30, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1236-2017

FDA classification

Class III

Brand / firm

Hidrex GmbH

Sold / distributed

Nationwide throughout the US

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Hidrex USA DP450