Events

Alerta De Seguridad para OXYGEN BRASS REGULATORS PRECISION MEDICAL EASY DIAL: (1) MODEL 168704DLB, (2) MODEL 168708DB, (3) MODEL 168708DLB, (4) MODEL 168715DB, (5) MODEL 168715DLB, (6) MODEL 168725DB. LOTS / DATE CODES: (1 THROUGH 6) 0999 À 0401 BODY STAMPS NEAR METAL ENTRY

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por PRECISION MEDICAL 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
    58
  • Fecha
    2001-04-27
  • 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
    The boards of these regulators were modified to reduce weight. these modifications allowed a user, without wishing, to place the regulator in the nitrogen valve position. the manufacturer began removal by a letter sent on april 24, 2001.
  • Acción
    VERIFY THAT YOU HAVE RECEIVED THE PRECISION MEDICAL LETTER OF APRIL 24, 2001 .. IDENTIFY AND ISOLE ANY OF THESE PRODUCTS THAT ARE IN YOUR INVENTORY. PRECISION MEDICAL ENSURES THAT ALL PRODUCTS RETURNED WILL BE REPLACED FREE OF CHARGE. TO RECEIVE THE RETURN AUTHORIZATION FORM CONTACT THE REMOVAL COORDINATOR BY E-MAIL REGULATOR@PRECISIONMEDICAL.COM OR BY PHONE 0021-1-610-262-6090. PRECISION MEDICAL REQUESTS YOUR NAME, ADDRESS, PHONE NUMBER AND CONTACT NAME, AND THE NUMBER OF REGULATORS TO BE REPLACED IN ORDER TO ISSUE THE RETURN AUTHORIZATION NUMBER. FOR FURTHER INFORMATION CONTACT YOUR REPRESENTATIVE OR MEDICAL PRECISION BY PHONE 0021-1-610-262-6090.

Device

OXYGEN BRASS REGULATORS PRECISION MEDICAL EASY DIAL: (1) MODEL 168704DLB, (2) MODEL 168708DB, (3)...

Manufacturer

PRECISION MEDICAL INC
  • Source
    ANVSANVISA