Events

Safety Alert for BASS PROFILE GASTROSTOMY REPLACEMENT KIT. Model: WIZARD. Anvisa Registry: 10178010088. Affected lots: several batches manufactured from 2003 to January 2008 (for details of batches affected, access http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/951_produtosafetados.pdf).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by POLITEC IMPORTAÇÃO E COMÉRCIO 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
    951
  • Date
    2009-01-16
  • 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 Politec Ltda, the product manufacturer (Bard Access System Inc.) started collecting the product due to constant complaints about valve breakage. This problem causes leakage of gastric contents and feed solutions, resulting in inconvenience to the user. According to the company, no damage, in addition to slight skin irritation, has been reported with valve breakage. UTVIG / Anvisa is following up on this case.
  • Reason
    The manufacturer of the product (company bard access systems) is collecting the product on the world market due to continuous valve breakdown claims.
  • Action
    The holder of the registration of the product in Brazil informed the UTVIG / Anvisa that it has already begun sending letters of communication to the distributors / users of the product, as well as the collection of affected lots. According to the company, it is not necessary to remove the already deployed devices. The user of the product should take the following measures: (1) Check for affected products in stock; (2) If affected products are found, immediately cease their use and distribution, segregating them immediately - identify with a label, to avoid inadvertent use; (3) Return the affected products to the registry holder Politec Imp. and Com. Ltda (address in the field Manufacturer's description) or to a distributor of the product; (4) Fill in the Product Collection Form (http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/951_carta.pdf) and send it to Politec Ltda, according to the instructions on the form itself.

Device

BASS PROFILE GASTROSTOMY REPLACEMENT KIT. Model: WIZARD. Anvisa Registry: 10178010088. Affected l...

Manufacturer

POLITEC IMPORTAÇÃO E COMÉRCIO LTDA.