Events

Safety Alert for Parenteral infusion set with side injector. Lots: 126L2, 213L2, 265L2, 317L2, and 039L2

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Plascalp Produtos Cirúrgicos 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
    700
  • Date
    2003-04-14
  • 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
    -Inspection made by technicians of the Inspection Unit - UINSP of the General Management of Technology for Health Products - GGTPS / ANVISA jointly with DIVISA / BA, from March 10 to 12, 2003, based on non-conformities reported through notifications of occurrences of adverse events issued through the Network of Sentinel Hospitals to the Technovigilance Unit - UTVIG / GGSPS / ANVISA.
  • Reason
    Occurrence of leakage of lateral injector after infusion.
  • Action
    The company will be replenishing the reclaimed lots (LTs: 126L2, 213L2, 265L2, 317L2, and 039L2) and contacting all customers and representatives to check if there are stock of the respective lots / products in order to carry out their replacement . If you own the listed lots in your stock, please contact your local representative or manufacturer by calling 071-343.8160 / 66 or SAC 0800714677.

Device

Parenteral infusion set with side injector. Lots: 126L2, 213L2, 265L2, 317L2, and 039L2

Manufacturer

Plascalp Produtos Cirúrgicos Ltda.
  • Source
    ANVSANVISA