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Terminated

Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester)

FDA Recall Z-0697-2008 · Posted 2008-02-05

Recalling FirmSakar International, Inc.
Recall StatusTerminated
Product CodeDJZ
Date Initiated2007-11-30
Date Terminated2010-06-30
Product Quantity72,581

Reason for Recall

Marketed without a 510(k)

Firm Action

Recall notification letters , Urgent Device Recall, were sent by first class mail on 11/30/2007 requesting return of product and notification of accounts sold product.

Root Cause

PMA

Distribution Pattern

Nationwide to retail distribution centers in CA, CO, IL, KS, MA, MO, NE, NJ, NY, PA, VA and WI.

Official Source

View FDA Recall →

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

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