Class 2 Device Recall Maximo Concepts

• Date Initiated by Firm: November 30, 2007
• Date Posted: February 05, 2008
• Recall Status: Terminated on June 30, 2010
• Recall Number: Z-0697-2008
• Recall Event ID: 45936
• Product Classification: Alcohol Breath Tester - Product Code DJZ
• Product: Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester)
• Code Information: Item Codes: MAX91721, MAX91721CL, MAX91721B, MAX91721-6, MAX91721CL-16, MAX91721CL-FR, MAC91721CL-PDQ and MAX91721B-DW. The device does not contain any serial or control/lot numbers.
• FEI Number: 3000203697
• Recalling Firm/ Manufacturer: Sakar International, Inc.; 195 Carter Drive; Edison NJ 08817-2068
• For Additional Information Contact: Marilu Bernabe-McGee; 732-476-5007
• Manufacturer Reason for Recall: Marketed without a 510(k)
• FDA Determined Cause: PMA
• 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.
• Quantity in Commerce: 72,581
• Distribution: Nationwide to retail distribution centers in CA, CO, IL, KS, MA, MO, NE, NJ, NY, PA, VA and WI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.