Recall Z-1237-2017— Hidrex GmbH
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: Hidrex USA DVP1000. 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 recordK-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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.