Z-1237-2017 Class III Terminated

Recalled by Hidrex GmbH — Heiligenhaus, N/A

Recall Details

Product Type
Devices
Report Date
March 1, 2017
Initiation Date
January 30, 2017
Termination Date
August 4, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
180 units

Product Description

Hidrex USA DVP1000

Reason for Recall

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

Distribution Pattern

Nationwide throughout the US

Code Information

SN# 16-3.6190 to 16-3.6319, 17-3.6001 to 17-3.6050