Events

Alerta De Seguridad para Emergency Lavoptik flushing flasks, face and body: (1) 16 oz., (2) 32 oz .; Lavoptik Concentrated Eye Wash Bottles: (3) 70 oz., (4) 180 oz .; Rapid Clear Eye Wash Bottles: (5) 16 oz., (6) 32 oz., (7) 128 oz .; (8) 6 oz. Lavoptik eye wash bottles; (9) 16 oz. Zee saline solution flasks; (10) 180 oz Rapid Clear Concentrated Eye Wash Bottles; (11) 5 qt. Zee Protector II (Zee Protector II Refill Eyewash Solution Bottles) Refill Bottle

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por H L Bouton 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
    209
  • Fecha
    2000-11-17
  • 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 manufacturer has removed these products because of improper labeling. at this point the manufacturer is removing the vials above because they may be contaminated with an aggressive biological agent in the eyes. the company did not provide any information to ecri.
  • Acción
    Make sure you have been contacted by HL Bouton. Identify and collect any affected product from your inventory. Discontinue use and dispose of the product, return any affected product to HL Bouton by mail to the address. For more information contact your local representative or directly with HL Bouton at 1 (508) 759-8000 in the United States.

Device

Emergency Lavoptik flushing flasks, face and body: (1) 16 oz., (2) 32 oz .; Lavoptik Concentrated...

Manufacturer

H L Bouton Co
  • Source
    ANVSANVISA