Events

Recall of One Touch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Milwaukee Notions, 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
    36663
  • Event Risk Class
    Class 1
  • Event Number
    Z-0263-2007
  • Event Initiated Date
    2006-10-10
  • Event Date Posted
    2006-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49114
  • 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
    Blood Glucose Test Strips - Product Code CGA
  • Reason
    Counterfeit (manufacturer unknown).
  • Action
    Firm started contacting pharmacists beginning 10/10/06. The phone call told the pharmacist that certain lots were identified by LifeScan as counterfeit and not to further distribute. Recontact on 10/27/2006 updated instructions to pharmacists to recall to the ''user/consumer'' level.

Device

One Touch
  • Model / Serial
    OneTouch Ultra, Lots 2691191 and 2691261.  OneTouch Basic/Profile, Lot 2615211
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution ---- including states of IL, KY, MA, MI, MN, NE, OH, PA, SD, and WI.
  • Product Description
    OneTouchBasic/Profile and OneTouch Ultra- Blood Glucose test strips. For use with ONE TOUCH Brand Meters.
  • Manufacturer
    Milwaukee Notions, Inc

Manufacturer

Milwaukee Notions, Inc
  • Manufacturer Address
    Milwaukee Notions, Inc, 1006 Vine Street, Union Grove WI 53182
  • Source
    USFDA