Events

Safety Alert for Hudson RCI Nebulizer, codes 031-28 and 031-33, registration no. 10342600026, batches affected - Annex

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Comercial Nacional de Produtos Hospitalares; Teleflex Medical.

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
    1441
  • Date
    2014-10-02
  • 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 manifestation of the company, to date no cases of adverse events have been identified. The company directs that the batches identified are not used as a precautionary measure, since this product must be sterile. Inquiries, please contact us at sac@cnph.com.br
  • Reason
    The manufacturer teleflex medical has identified that the nebulizer adapter packaging may be open or the sealing may be poor, which may affect the sterility of the product. the adapter is a sterile product.
  • Action
    The company that owns the registration in Brazil is collecting the product. It instructs customers and distributors to segregate and return the products of the lots involved in this field action

Device

Hudson RCI Nebulizer, codes 031-28 and 031-33, registration no. 10342600026, batches affected - A...

Manufacturer

Comercial Nacional de Produtos Hospitalares; Teleflex Medical
  • Source
    ANVSANVISA