Devices

Device Recall Maximo Concepts

  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide to retail distribution centers in CA, CO, IL, KS, MA, MO, NE, NJ, NY, PA, VA and WI.
  • Description du dispositif
    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

Fabricant

Sakar International, Inc.
  • Adresse du fabricant
    Sakar International, Inc., 195 Carter Drive, Edison NJ 08817-2068
  • Société-mère du fabricant (2017)
    Sakar International Inc.
  • Source
    USFDA