Events

Safety Alert for Hydrothermal Gauze Surgical Compressor Sterile Hérika / 11 threads with 10 units 7.5x 7.5cm, register 80037490012, risk class II, affected lot: 0623.

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
    1642
  • Date
    2015-07-14
  • 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
    Report of Analysis OS nº 115.50743, referring to the product Surgical Compresses of Hydrophilic Gauze, manufacturer América Medical Ltda, Lot 0623, with unsatisfactory report, resulting in precautionary interdiction of the product by Sanitary Surveillance.
  • Reason
    Foreign body identification inside a sealed envelope with 10 product units.
  • Action
    The company advises customers to carry out product segregation. Subsequently, the product will be collected. In case of other deviations of quality referring to this batch, the company must be communicated.

Device

Hydrothermal Gauze Surgical Compressor Sterile Hérika / 11 threads with 10 units 7.5x 7.5cm, regi...

Manufacturer

América Medical Ltda.
  • Source
    ANVSANVISA