Events

Safety Alert for R503, (3) MEDIUM AND LOW, MODEL R502, (4) MEDIUM AND LOW, MODEL R504, (5) SMALL AND RIGHT, MODEL R505, (2) LOW, MODEL R501. ALL SERIAL NUMBERS.

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

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
    42
  • Date
    2001-05-05
  • 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
    The plastic plaster in which the clamps, which support the seat, must be inserted, can break. the manufacturer started the voluntary removal day, january 8, 2001.
  • Action
    MAKE SURE YOU HAVE RECEIVED THE VOLUNTARY REMOVAL LETTER FROM THE COMMUNITY PRODUCTS ON JANUARY 8, 2001. IDENTIFY AND DISCONTINUE THE USE OF ALL THESE AFFECTED PRODUCTS THAT ARE IN YOUR INVENTORY. FOR FURTHER INFORMATION CONTACT YOUR DISTRIBUTOR OR MANUFACTURER ON YOUR PHONE (00XX-1-845-658-8799).

Device

R503, (3) MEDIUM AND LOW, MODEL R502, (4) MEDIUM AND LOW, MODEL R504, (5) SMALL AND RIGHT, MODEL ...

Manufacturer

PRODUTOS COMUNITÁRIOS LLC
  • Source
    ANVSANVISA