Events

Recall of DIGITOUCH POWDERED LATEX EXAMINATION GLOVES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TG MEDICAL SDN. BHD..

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
    49192
  • Event Risk Class
    II
  • Event Initiated Date
    2006-04-02
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Device labelling is not in compliance with s.21 of the mdr -- manufacturer name and address is not present on the label.

Device

DIGITOUCH POWDERED LATEX EXAMINATION GLOVES
  • Model / Serial
    Model Catalog: EXTRA LARGE-5004 (Lot serial: ALL); Model Catalog: EXTRA SMALL-5000 (Lot serial: ALL); Model Catalog: LARGE-5003 (Lot serial: ALL); Model Catalog: MEDIUM-5002 (Lot serial: ALL); Model Catalog: SMALL-5001 (Lot serial: ALL)
  • Product Description
    DIGITOUCH POWDERED LATEX EXAM GLOVES
  • Manufacturer
    TG MEDICAL SDN. BHD.

Manufacturer

TG MEDICAL SDN. BHD.
  • Manufacturer Address
    KLANG
  • Source
    HC