Events

Safety Alert for COMPRESSA SURGICAL GAZE HYDROPHILASE ESTERIL HERIKA, lot 0155 and lot 191012G11 - registration no. 80037490003

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
    1368
  • Date
    2013-11-27
  • 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
    Services that have units of these lots should contact the company to arrange for the collection.
  • Reason
    Reprocessing in the aspect test of the product compressa surgical gaze hydrophila esteril herika, in accordance with the single sample analysis report 113.479 / 2013, issued by lacen ba, for lot 191012g11. presence of foreign body in inviolate packaging of lot 0155, as published in official gazette of the city of são paulo on 10/9/2013.
  • Action
    Resolution RE No. 4,937 of December 23, 2013 was published, determining, as a measure of health interest, the suspension of distribution, trade and use, as well as the collection, throughout the national territory, of the product COMPRESSA SURGICAL SURGERY OF GAZE HYDROPHILA ESTERIL HERIKA , lot 191012G11. The COVISA Communiqué 029/2013 was published in the Official Gazette of the City of São Paulo on October 9, 2013, determining the interdiction and collection of the product COMPRESSA SURGICAL GAZE HYDROPHILA ESTERIL HERIKA, lot 0155.

Device

COMPRESSA SURGICAL GAZE HYDROPHILASE ESTERIL HERIKA, lot 0155 and lot 191012G11 - registration no...

Manufacturer

América Medical Ltda
  • Source
    ANVSANVISA