Events

Alerta De Seguridad para PROCIDE-D PLUS DISINFECTANT AND STERILIZING SOLUTIONS

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por METREX DIV SYBRON DENTAL SPECIALTIES INC.

¿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
    163
  • Fecha
    2000-10-27
  • 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
    Part of the lots of the products mentioned have been incorrectly labeled as procide-d plus, which contains 3.4% glutaraldehido, other than procide-d, which contains 2,5% glutaraldehido. syron dental specialties began a correspondence removal dated 7 august 2000. the firm has provided no information to ecri.
  • Acción
    MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCE OF 7 AUGUST 2000 SUBMITTED BY SYBRON DENTAL SPECIALTIES. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH SYBRON DENTAL SPECIALTIES BY PHONE 1 (800) 841-1428.

Device

PROCIDE-D PLUS DISINFECTANT AND STERILIZING SOLUTIONS

Manufacturer

METREX DIV SYBRON DENTAL SPECIALTIES INC
  • Source
    ANVSANVISA