Recall Z-1238-2017
Hidrex GmbH · initiated January 30, 2017
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Daavlin Aquex (DAAV1000)
Codes / lots: SN# 16-3.8001 to 16-3.8250
Reason for recall
The device was reclassified from a class III device to a class II device and there are new documentation requirements.
FDA-determined cause: Error in labeling
Action taken
Distributor sent recall notification letter to affected dealers and end users on 2/10/17. Notification letter will include a copy of the addendum to the user manual. The device is not instructed to be returned.
Details
- Recall number
- Z-1238-2017
- Initiated
- January 30, 2017
- Posted by FDA
- February 22, 2017
- Terminated
- August 4, 2017
- Product code
- EGJ – Device, Iontophoresis, Other Uses
- Quantity
- 250 units
- Distribution
- Nationwide throughout the US
- Recalling firm
- Hidrex GmbH, Heiligenhaus
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1236-2017 Class III | Hidrex USA DP450The device was reclassified from a class III device to a class II device and there are new documentation… | 01/30/2017Terminated |
| Z-1237-2017 Class III | Hidrex USA DVP1000The device was reclassified from a class III device to a class II device and there are new documentation… | 01/30/2017Terminated |