Recall Z-0697-2008 ยท DJZ Devices, Breath Trapping, Alcohol
Sakar International, Inc.
Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester)
| Date | Feb 5, 2008 (initiated Nov 30, 2007) |
| Status | Terminated |
| Reason | Marketed without a 510(k) |
| 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 | 72,581 |
| Distribution | Nationwide to retail distribution centers in CA, CO, IL, KS, MA, MO, NE, NJ, NY, PA, VA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.