Events

Safety Alert for BLAKE / J-VAC Silicone Drains (Anvisa Registry: 80145900995); Silicone Drains with Trocarte BLAKE / J-VAC (Registro Anvisa: 80145901014); J-VAC Drainage System (Anvisa Record: 10132590602). See list of affected lots at http://portal.anvisa.gov.br/wps/wcm/connect/bf9d8f0046a11aa69f919fc9c474c85c/Lotes+afetados.pdf?MOD=AJPERES

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson Medical Brasil 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
    1054
  • Date
    2011-04-25
  • 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 Johnson & Johnson Medical Brazil Ltda, the sterile barrier of the products may have been damaged and there is a possibility that the use of these products may result in the introduction of pathogens into patients. According to the company, this may not be clinically significant or may lead to a clinical picture of infection, which in itself may be of limited clinical significance or may result in serious injury or death.
  • Reason
    Potential impairment of the sterile product packaging barrier.
  • Action
    Users of the cited products shall (1) verify their stock and immediately discontinue use of the affected products and lots; and (2) Report Johnson & Johnson Ltd. on affected products located in stock, following the instructions provided by the company (see http://portal.anvisa.gov.br/wps/wcm/connect/d057c60046a118569f609fc9c474c85c/Carta+ to the + user% C3% A1.pdf? MOD = AJPERES).

Device

BLAKE / J-VAC Silicone Drains (Anvisa Registry: 80145900995); Silicone Drains with Trocarte BLAKE...

Manufacturer

Johnson & Johnson Medical Brasil Ltda.