Events

Safety Alert for DOSI-FUSER, model L25915-2020D2; record 80003610133, hazard class II, batch number: 142100L.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Werfen Medical Ltda; Leventoon SAL.

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
    1711
  • Date
    2015-10-05
  • 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
    According to the registry holder, if the product is used, the infusion time will be longer than expected or the infusion will be interrupted. The lot was distributed only in the city of Porto Alegre.
  • Reason
    Some batches may show reduced flow in capillaries being detected before use (flow is less than expected).
  • Action
    Collection and destruction of distributed products. Action code: FSN01 / 15

Device

DOSI-FUSER, model L25915-2020D2; record 80003610133, hazard class II, batch number: 142100L.

Manufacturer

Werfen Medical Ltda; Leventoon SAL