Hidrex GmbH recalls Daavlin Aquex (DAAV1000)
- Recall date
- January 30, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1238-2017
- FDA classification
- Class III
- Brand / firm
- Hidrex GmbH
- Sold / distributed
- Nationwide throughout the US
Why it was recalled
The device was reclassified from a class III device to a class II device and there are new documentation requirements.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Daavlin Aquex (DAAV1000)
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