Z-1238-2017 Class III Terminated
FDA device recall Z-1238-2017 was initiated by Hidrex GmbH on January 30, 2017 and is designated Class III. Reason for recall: The device was reclassified from a class III device to a class II device and there are new documentation requirements. The recall status is terminated (terminated August 4, 2017). Affected quantity: 250 units.
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
- 250 units
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.
Distribution Pattern
Nationwide throughout the US
Code Information
SN# 16-3.8001 to 16-3.8250