Events

Recall of Device Recall Maximo Concepts

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sakar International, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    45936
  • Event Risk Class
    Class 2
  • Event Number
    Z-0697-2008
  • Event Initiated Date
    2007-11-30
  • Event Date Posted
    2008-02-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66520
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Alcohol Breath Tester - Product Code DJZ
  • Reason
    Marketed without a 510(k).
  • 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.

Device

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.

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