Events

Safety Alert for MODEL A-6002 PLEUR-EVAC PLEURAL DRAIN SYSTEM, LOT NO. 412335

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

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
    48
  • Date
    2001-06-08
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    A fixture in the wall of the system chamber can commit the water sealing of the thoracic drain. the manufacturer started the removal by letter sent on october 27, 2000. the signature given no information to ecri.
  • Action
    VERIFY THAT YOU HAVE RECEIVED THE GENZYME BIOSURGERY REMOVAL LETTER ON OCTOBER 27, 2000. IDENTIFY, ISOLE AND DO NOT USE THESE PRODUCTS. FOR FURTHER INFORMATION CONTACT YOUR GENZYME BIOSURGERY REPRESENTATIVE OR PHONE (0021-1-617-252-7500).

Device

MODEL A-6002 PLEUR-EVAC PLEURAL DRAIN SYSTEM, LOT NO. 412335

Manufacturer

GENZYME BIOSURGERY
  • Source
    ANVSANVISA