Maximo Concepts Alcohol Breath Tester…

Date posted by the FDA

Feb. 5, 2008

Status

Terminated

Filed by

Sakar International, Inc.

Product

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

Reason

Marketed without a 510(k)

Distribution pattern

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

Quantity

72,581

Codes and lots

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.

Recall started

Nov. 30, 2007

Device type

Devices, Breath Trapping, Alcohol

Root cause (FDA)

PMA

What the company told customers

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.

Recall number

Z-0697-2008

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0697-2008. The agency record governs; check it and the company before acting.