Events

Safety Alert for 3mL disposable hypodermic safety syringe, safety jet model, registration 10369460028, hazard class II, lots: 101208.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Labor Import Comercial Importadora Exportadora Ltda.; Shandong Weigao Group Medical Polymer Co..

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
    1617
  • Date
    2015-06-15
  • 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 quality deviation was found in a single sample of the batch.
  • Reason
    A foreign body was found inside a sealed unit.
  • Action
    The company will collect and destroy the product. If you have the product contact the record holder.

Device

3mL disposable hypodermic safety syringe, safety jet model, registration 10369460028, hazard clas...

Manufacturer

Labor Import Comercial Importadora Exportadora Ltda.; Shandong Weigao Group Medical Polymer Co.
  • Source
    ANVSANVISA