Events

Alerta De Seguridad para 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.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por PRODUTOS COMUNITÁRIOS LLC.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    42
  • Fecha
    2001-05-05
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    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.
  • Acción
    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