Events

Recall of G.O.L.F.F. - (ANTI-FOG SOLUTION FOR ENDOSCOPES)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BATRIK MEDICAL MANUFACTURING 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
    45980
  • Event Risk Class
    II
  • Event Initiated Date
    2014-10-03
  • 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
    As a result of an investigation following a customer complaint for the the golff-ro (g.O.L.F.F.-anti-fog solution) lot no. 49691 we have uncovered that the labels on the sterile pouches may have an expiry date error of 2018-14. the outer boxes have the correct expire date: 2018-04 however some pouches within these boxes have been labeled correctly with the correct expire date being: 2018-04 and some have been labeled incorrectly with the incorrect expiry date being 2018-14.

Device

G.O.L.F.F. - (ANTI-FOG SOLUTION FOR ENDOSCOPES)
  • Model / Serial
    Model Catalog: G.O.L.F.F. (Lot serial: 49691)
  • Product Description
    G.O.L.F.F.-(ANTI-FOG SOLUTION FOR ENDOSCOPES)
  • Manufacturer
    BATRIK MEDICAL MANUFACTURING INC.

Manufacturer

BATRIK MEDICAL MANUFACTURING INC.