Events

Safety Alert for Catheter for intracranial pressure, model 110-4L, hazard class IV, record 10099430123. Serial number / lot affected: 30500X309674.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by DABASONS Importação Exportação e Comércio Ltda.; Integra Lifesciences Corporation.

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
    1603
  • Date
    2015-05-22
  • 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
    The record holder has reported that all products specified in this field action are in stock.
  • Reason
    Manufacturer integra lifesciences has identified batches of improperly assembled intracranial pressure monitoring cata- tes. the ring of the screw adapter may be in the wrong place and there is a potential risk of blood leakage from the adapter.
  • Action
    The company that holds the registration will collect the product for return to the manufacturer. We ask users of this type of product to verify that they own the model products and the affected series. If you have the specified product, discontinue use and contact the holder.

Device

Catheter for intracranial pressure, model 110-4L, hazard class IV, record 10099430123. Serial num...

Manufacturer

DABASONS Importação Exportação e Comércio Ltda.; Integra Lifesciences Corporation
  • Source
    ANVSANVISA