Events

Safety Alert for External sewage pump Architect no. List 8C94-99. External sewage pump Aeroset no. List 9D61-01

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott Laboratórios 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
    713
  • Date
    2003-03-26
  • 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
    For laboratories that do not use an external sewage pump, there are no actions to be taken. There are no maintenance procedures that require operator intervention at the pump. Caution: When handling the sewage pump, ensure that adequate personal protective equipment is used. As a precaution, avoid contact with the metal end of the external sewage pump.
  • Reason
    The abbott laboratories - diagnostic division has identified a potential risk in handling the external sewage pump used in the architect and aeroset systems. this pump is an optional component for use in architect and aeroset systems. the metal end around the perimeter of the sewage pump can cause scratches or cuts if not handled with care.
  • Action
    Corrective actions are being implemented to eliminate this potential risk. External sewage pumps currently in use will be reviewed by ABBOTT representatives for removal of any end that poses a potential hazard.

Device

External sewage pump Architect no. List 8C94-99. External sewage pump Aeroset no. List 9D61-01

Manufacturer

Abbott Laboratórios do Brasil LTDA
  • Source
    ANVSANVISA