Events

Recall of Device Recall One Touch Basic/Profile

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Royal Global Wholesale.

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
    36696
  • Event Risk Class
    Class 1
  • Event Number
    Z-0265-2007
  • Event Initiated Date
    2006-11-01
  • Event Date Posted
    2006-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49182
  • 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 glucose test strips (manufacturer unknown).
  • Action
    The firm notified its consignees by phone and issued a recall letter on 11/3/2006. Consumers who have the product were advised to destroy the product or return it to the retail outlet where it was purchased.

Device

Device Recall One Touch Basic/Profile

Manufacturer

Royal Global Wholesale
  • Manufacturer Address
    Royal Global Wholesale, 5681 Northpointe Lane, Boynton Beach FL 33437
  • Source
    USFDA