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Recall Observatory FDA recall evidence

Device product

Daavlin Aquex (DAAV1000)

Z-1238-2017

January 30, 2017

Class III

Product summary

Firm
Hidrex GmbH
Event
Event 76362
Status
Terminated
Classification
Class III
Quantity
250 units
Official record key
device-enforcement:Z-1238-2017

Official wording

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

Code information: SN# 16-3.8001 to 16-3.8250

Distribution pattern: Nationwide throughout the US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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