Events

Safety Alert for RESPIRATOR EXHAUST VALVES VALVE ASSEMBLIES

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by INSTRUMENTATION INDUSTRIES INC.

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
    156
  • Date
    2000-07-24
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    Rings used in the diaphragm mechanism were inadvertely molded with the wrong nucleus pin, which could result in the leakage of the expiration valve if processed and remote. the manufacturer started a removal by correspondence dated 24 july 2000.
  • Action
    MAKE SURE THAT YOU HAVE RECEIVED THE DATED CHECK OF 24 JULY 2000 FROM INSTRUMENTATION INDUSTRIES. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. FOR PRODUCT REPLACEMENT OR FOR FURTHER INFORMATION, CONTACT YOUR INSTRUMENTATION INDUSTRIES REPRESENTATIVE

Device

RESPIRATOR EXHAUST VALVES VALVE ASSEMBLIES

Manufacturer

INSTRUMENTATION INDUSTRIES INC
  • Source
    ANVSANVISA