Z-0697-2008

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

Name: Z-0697-2008 Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3...
Creator: Sakar International, Inc.
Published: 2007-11-30
License: https://open.fda.gov/license/

Sakar International, Inc. / initiated 2007-11-30 / Terminated

FDA source

Sakar International, Inc. began a recall of Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester) on 2007-11-30. The reason FDA records is "Marketed without a 510(k)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0697-2008
Status: Terminated
Initiated: 2007-11-30
Posted: 2008-02-05
Terminated: 2010-06-30
Recalling firm: Sakar International, Inc.
Product: Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester)
Product code: DJZ Devices, Breath Trapping, Alcohol
Reason for recall: Marketed without a 510(k)
FDA root 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.
Product 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.

Product code DJZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)