Events

Safety Alert for EXTENSOR FOR RESONANCE AND TOMOGRAPHY (RT12000V) - Registration No. 10216839006 - Batches 11E03; 11D27; 11D28; 11C18 ### SMARTSITE GABMED VALVE EXTENSOR (GB71230) - Registration No. 10216830035 - Batches 11G09; 12A21; 12C14 ### EXTENSOR FOR RESONANCE AND TOMOGRAPHY (RT12200) - Registration No. 10216830048 - Lots 11E11; 11F05; 11F18 ### EXTENSOR WITH GABMED MULTIVALVULATED TAP (GB61222) - Registration No. 10216830052 - Batches 11E04; 11F06 ### INFUSION EQUIPMENT WITH GABMED VALVULATED SIDE INJECTOR (RT12400) - Registration No. 10216830046 - Lot 12B13.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GaBmed Produtos Específicos 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
    1191
  • Date
    2012-10-08
  • 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 component used for connection (Y connector) was produced in flexible PVC and did not generate mechanical resistance (hardness) with the other components of the product when being glued, being possible cracks in the component body or leakage in the thread.
  • Reason
    Product leaks on your connection.
  • Action
    Observe the integrity of the product before use. If the product shows the quality deviation mentioned above, immediately inform the responsible manufacturer or distributor.

Device

EXTENSOR FOR RESONANCE AND TOMOGRAPHY (RT12000V) - Registration No. 10216839006 - Batches 11E03; ...

Manufacturer

GaBmed Produtos Específicos Ltda.