Events

Safety Alert for PLASTIC BAG FOR PLASMA TRANSFER, Model: S-41, 300ml, registration 10344080018, risk class III, lot: 0527482.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Ribral Ltda; P.L. Rivero y Cia S.A..

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
    1821
  • Date
    2016-01-14
  • 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
    Additional recommendations for clients, users, patients, written clearly, objectively and succinctly. Describe in up to 500 characters
  • Reason
    The bacterial endotoxin tests were unsatisfactory.
  • Action
    Gathering. The company will collect the product and repeat the tests for bacterial endotoxin. The company advises not to use the product. Any questions about this field action contact by email: ribral@ribral.com.br

Device

PLASTIC BAG FOR PLASMA TRANSFER, Model: S-41, 300ml, registration 10344080018, risk class III, lo...

Manufacturer

Ribral Ltda; P.L. Rivero y Cia S.A.
  • Source
    ANVSANVISA