Events

Safety Alert for CONTAINER STRYKER (12 Instrument Sterilization Tray). Model under risk: 00-000-242-0000-12. Anvisa Registry n ° 80005439008.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by STRYKER DO BRASIL LTDA..

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
    1468
  • Date
    2014-12-01
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    The gravity steam sterilization method (121øC to 30 minutes) was removed from the reprocessing guide (1000400920, Rev. D), because of the remote possibility of infection. The download of the new Reprocessing Guide, part number 1000400920 Rev. E, should be done from the link URL: www.stryker.com/12instrumenttray
  • Reason
    The gravity sterilization parameters provided in the sterilization reprocessing guide of 12 instruments (1000400920 rev. d) did not fully consider all worst case scenarios during the validation tests, and there is a possibility of infection.
  • Action
    Updating Instructions for Use Information. The product user should discard any prior use instructions for his 12 Instrument Sterilization Tray and download the new reprocessing guide (Rev E) made available by the company (see CLARIFICATION field).

Device

CONTAINER STRYKER (12 Instrument Sterilization Tray). Model under risk: 00-000-242-0000-12. Anvis...

Manufacturer

STRYKER DO BRASIL LTDA.
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    ANVSANVISA