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Devices
Device Recall Maximo Concepts
Model / Serial
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 Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide to retail distribution centers in CA, CO, IL, KS, MA, MO, NE, NJ, NY, PA, VA and WI.
Product Description
Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester)
Manufacturer
Sakar International, Inc.
1 Event
Recall of Device Recall Maximo Concepts
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Manufacturer
Sakar International, Inc.
Manufacturer Address
Sakar International, Inc., 195 Carter Drive, Edison NJ 08817-2068
Manufacturer Parent Company (2017)
Sakar International Inc.
Source
USFDA
Language
English
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