Events

Safety Alert for 10362890006 - Neonatal Poly-Brasino Two-Way Device

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.

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
    1017
  • Date
    2010-04-26
  • 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
    This sanitary measure was taken based on the Single Sample Fiscal Analysis Report No. 38.00 / 2010 issued by LACEN / PR, which found that inside the packaging of the NEONATAL PRODUCT OF TWO-WAY POLI-BRASINO there was no equipment for neonatal use, but for use in other age groups.
  • Reason
    Suspension of distribution, commerce and use, throughout the national territory, as well as the collection of lot 200209a of the neonatal device of two-ways poli-brasino, imported by kdl comércio de produtos médico-hospitalares ltda, located at rua eduardo froner nº 850, parque cid. brasília, guarulhos - sp.
  • Action
    According to routine UTVIG / NUVIG / ANVISA, the company was asked to keep the UTVIG informed and updated of the progress of the batch process 200209A.

Device

10362890006 - Neonatal Poly-Brasino Two-Way Device

Manufacturer

ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD