Events

Alerta De Seguridad para KENDALL STERILIZED PROCESSING KITS WHICH CONTAIN CLINICALLY ANTI-SEPTIC PRODUCTS ALREADY REVISED: (1) CURITY, (2) KENDGUARD, (3) SAGE; PRIVATE LABEL STERILE (4) ALLEGIANCE, (5) SOURCE, (6) RESPIRATORY SUPPORT PRODUCTS

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por KENDALL CO A TYCO HEALTHCARE GROUP CO.

¿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
    121
  • Fecha
    2000-03-31
  • 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 above mentioned kits, kits, and tablets contain anti-sepsis products which may be contaminated by bacteria and / or antiseptic products labeled as sterile and which are not capable of ensuring their sterility. kendall began a recall through correspondence sent on march 24, 2000. the manufacturer provided no information to ecri.
  • Acción
    MAKE SURE THAT YOU HAVE RECEIVED THE LETTER OF MARCH 24, 2000 AND KENDALL LABELS. IDENTIFY AND COLLECT ANY AFFECTED PRODUCT FROM YOUR INVENTORY. PUT THE LABELS ON ANY DAMAGED PRODUCT AND COLLECT / DISPOSE ANY ANTI-SEPTIC PRODUCT CLINIC OF THE KITS. FOR FURTHER INFORMATION, CONTACT KENDALL'S LOCAL CONSUMER SERVICE OR TELEPHONE 1 (508) 261-8000 IN THE UNITED STATES.

Device

KENDALL STERILIZED PROCESSING KITS WHICH CONTAIN CLINICALLY ANTI-SEPTIC PRODUCTS ALREADY REVISED:...

Manufacturer

KENDALL CO A TYCO HEALTHCARE GROUP CO
  • Source
    ANVSANVISA