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 Medishop USA.

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
    36622
  • Event Risk Class
    Class 1
  • Event Number
    Z-0207-2007
  • Event Initiated Date
    2006-10-17
  • Event Date Posted
    2006-12-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49018
  • 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 NBW
  • Reason
    Counterfeit-(manufacturer unknown).
  • Action
    The recalling firm faxed, e-mailed and/or mailed ''Urgent Medical Device'' letters and response forms (dated 10/17/06) to the 5 distributor accounts.

Device

ONE TOUCH
  • Model / Serial
    Lots 2606340, 2619932, 272894A; Part # 020-848.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-including the states of NY, NJ, MS and country of Canada
  • Product Description
    OneTouch¿/Basic¿/Profile¿ Blood Glucose Test Strips, 50 Test Strips per box. Part Number 020-848, LIFESCAN, a Johnson & Johnson company. (The product is labeled in English, Greek and Portuguese)
  • Manufacturer
    Medishop USA

Manufacturer

Medishop USA
  • Manufacturer Address
    Medishop USA, 6 Bay St Fl 4th, Brooklyn NY 11231-1902
  • Source
    USFDA