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Terminated

Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: 115v for USA users & 220v for foreign countries. --- Chiu Technical Corporation, 252 Indian Head Road, Kings Park, NY 11754.

FDA Recall Z-0320-2008 · Posted 2008-01-09

Recalling FirmChiu Technical Corp
Recall StatusTerminated
Product CodeHJM
Date Initiated2007-11-09
Date Terminated2012-10-17
Product QuantityDomestic: 170 units, Foreign: 21 units

Reason for Recall

Device was marketed without a 510(k).

Firm Action

On 11/09/07, the recalling firm started faxing the Recall Letter and response form to its customers, informing them of the recall of the unapproved device to the user level.

Root Cause

Process design

Distribution Pattern

Worldwide: USA, Canada and India

Official Source

View FDA Recall →

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

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