Events

Safety Alert for CUTTING INSTRUMENT FORMULA. Registro Anvisa n ° 80005430103. Products with the following codes and lots mentioned on the labels: REF 275-545-000 and LOT 06033AG2; REF 275-542-000 and LOT 06115AG2; REF 275-552-000 and LOT 05110AG2; REF 3050-202-000 and LOTE050217; and LAMP SHAVER LOT 06312CG2.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

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
    1192
  • Date
    2012-10-09
  • 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
    According to the record holder - STRYKER DO BRASIL LTDA - the aforementioned batches and references are of unknown origin.
  • Reason
    Falsification of product for health.
  • Action
    Anvisa determined the seizure and destruction, throughout the national territory, of the product similar to the Health Product, named "INSTRUMENTO DE CUT FORMULA", with the codes and lots mentioned in the Product Description field of this alert. Check your inventory for the existence of counterfeit products, segregate them if identified, and contact the nearest Sanitary Surveillance for the product to be seized.

Device

CUTTING INSTRUMENT FORMULA. Registro Anvisa n ° 80005430103. Products with the following codes an...
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA