Events

Safety Alert for Commercial Name: HMEF Cellulose Filter Technical Name: Electrostatic Filter with Heat Exchanger and Cellulose Moisture Exchanger ANVISA Registration Number: 80158680018 Hazard Class: II Model Affected: 4333 / 761PUBA Serial Number Affected: L5012678

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GVS do Brasil Ltda; GVS 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
    2199
  • Date
    2016-12-20
  • 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
    When opening the primary packaging, make sure that the product is properly sealed.
  • Reason
    Upon becoming aware of the notification, gvs started the traceability of the lots and called its representative, not region - ilhatec, e-mail mr. bruno, dated 10/26/2016 - to schedule a visit to the responsible in the hospital, and if you still have pieces of the same batch reclaimed in stock for replacement, etc ... after the distributor's visit to the hospital, we had the information that it was a single part with the problem and that the rest of the lot is still used normally. in parallel, gvs had filed a complaint with the filter manufacturing supplier to initiate the cause analysis and to define corrective actions in order to avoid recurrence of the problem. on 10/27/2016, he responded to us with due treatment. they are: changing the manufacturing process and manual testing, from the filter to the automatic production line and automatic testing, avoiding operational failures.
  • Action
    Field Action Code RNC 121/2016 triggered under the responsibility of the company GVS do Brasil Ltda. Company will make information and replacement.

Device

Commercial Name: HMEF Cellulose Filter Technical Name: Electrostatic Filter with Heat Exchanger a...

Manufacturer

GVS do Brasil Ltda; GVS do Brasil Ltda
  • Source
    ANVSANVISA