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Terminated

MIRA CR4060 68 mm Finger Probe 68mm surf ace x 37mm Length Intended for the destruction of tumors.

FDA Recall Z-1920-2010 · Posted 2010-06-29

Recalling FirmMira, Inc.
Recall StatusTerminated
Product CodeHPS
Date Initiated2010-04-08
Date Terminated2016-08-08
Product Quantity5 units

Reason for Recall

Devices distributed without an approved 510(k)

Firm Action

Mira contacted accounts by email between 4/08/10-05/21/10 requesting return of inventory.

Root Cause

PMA

Distribution Pattern

Worldwide Distribution -- USA, including the state of NY and the countries of Israel and Italy.

Official Source

View FDA Recall →

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

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