Events

Safety Alert for Gloves for Surgery GAMMEX Non-Latex Antimicrobial

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Ansell Lanka (Pvt.), Ltd || Ansell Healthcare Products Llc || Ansell N.P. Sdn. Bhd..

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
  • Event ID
    R1511-508
  • Event Number
    2015DM-0013627
  • Date
    2015-11-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=167
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer indicates that it has been able to detect the possible presence of holes or perforations in the medical devices of the referenced lots, leading to possible adverse events due to contamination on the patients or users.

Device

Gloves for Surgery GAMMEX Non-Latex Antimicrobial
  • Model / Serial
    GAMMEX PF, lots 1411591004, 1411595604, 1412600604, 1412602604, 1412604004, 1412612804, 1501409504 and || 1503446404.
  • Product Description
    The surgical gloves in POLISOPRENE GAMMEX NON-LATEX ANTIMICROBIAL are designed to serve as a bidirectional barrier between the patient and the surgeon, preventing contamination during the surgical procedures and providing additional protection to the surgeon's hands avoiding contamination with infectious agents.
  • Manufacturer
    Ansell Lanka (Pvt.), Ltd || Ansell Healthcare Products Llc || Ansell N.P. Sdn. Bhd.

Manufacturer

Ansell Lanka (Pvt.), Ltd || Ansell Healthcare Products Llc || Ansell N.P. Sdn. Bhd.