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Terminated

Daavlin Aquex (DAAV1000)

FDA Recall Z-1238-2017 · Posted 2017-02-22

Recalling FirmHidrex GmbH
Recall StatusTerminated
Product CodeEGJ
Date Initiated2017-01-30
Date Terminated2017-08-04
Product Quantity250 units

Reason for Recall

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

Firm Action

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.

Root Cause

Error in labeling

Distribution Pattern

Nationwide throughout the US

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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