Recall Z-1238-2017— Hidrex GmbH

Name: FDA recall Z-1238-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-30

Class III · Terminated

Class III FDA medical device recall by Hidrex GmbH, initiated 2017-01-30, terminated 2017-08-04. It names one FDA 510(k) clearance: K133033. Product: Daavlin Aquex (DAAV1000). Reason: The device was reclassified from a class III device to a class II device and there are new documentation requirements..

Recalling firm: Hidrex GmbH
Classification: Class III
Status: Terminated
Initiated: 2017-01-30
Terminated: 2017-08-04
Firm location: Heiligenhaus, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K133033 — HIDREX PSP1000Hidrex GmbH·cleared 2015-04-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Daavlin Aquex (DAAV1000)

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.