Safety Alert for Lift Medical Adhesive Remover, 100 ml Bottle

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Opus Healthcare.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-07-17
  • Event Date Posted
    2013-07-17
  • Event Country
  • Event Source
    DH
  • Event Source URL
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: opus healthcare lift medical adhesive remover, 100 ml bottle the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning lift medical adhesive remover, 100 ml, manufactured by opus healthcare, a division of alliance pharmaceuticals limited. the affected products have product code of 5501, batch code of m364 and expiry date of sep 2015. opus healthcare is withdrawing the affected products following an observation of a “cloudy solution” of the lift medical adhesive remover which has subsequently been attributed to microbial contamination. according to opus healthcare, there is little risk to the health of healthy individuals; however there may be a small risk of opportunistic infection developing in those whose immune systems are compromised due to illness or therapies. therefore, regardless of the appearance of the product from the affected batch, all bottles of the affected batch need to be returned. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con287037 if you are in possession of the product, please contact your supplier for necessary actions. posted on 17 july 2013.

Device

  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Opus Healthcare Lift Medical Adhesive Remover, 100 ml Bottle
  • Manufacturer

Manufacturer