Events

Safety Alert for STERILE OPERATING FIELD, 13 WIRES WITH 05 UNITS lot 0477 - Record nº 80037490007

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by América Medical 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
    1580
  • Date
    2015-05-15
  • 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 company requests that the product should not be used and that the services that may have units of this lot should contact the company so that it can arrange the collection by means of the email gqt@americamedical.net
  • Reason
    Disappearance in the product aspect test sterile operating field, according to the single sample analysis report 114.198945, issued by lacen ba, for lot 0477.
  • Action
    The Sanitary Surveillance of the State of Minas Gerais published a Notice of Interdiction of Caution of the Collegiate Management of the Superintendence of Sanitary Surveillance / 09 / DVMC / 2015, on January 23, 2015. The company is performing the product collection.

Device

STERILE OPERATING FIELD, 13 WIRES WITH 05 UNITS lot 0477 - Record nº 80037490007

Manufacturer

América Medical Ltda
  • Source
    ANVSANVISA