Events

Alerta De Seguridad para BIOVUE Peripherally Inserted Central Catheters (PICC) and Central Line Catheters: (1) No Latex, (2) Com-Latex; Catheterization Kits with Procedure Tray, PROTECTIV Safe Introduction System, and Family of Polyurethane Catheters OCRILON II BIOVUE (3) 16 G 5 Fr Dual Lumen PICC, (4) 18 G 4 Fr Double Lumen Central Line, (5) 18 G 4 Fr Lumen Double PICC, (6) 18 G 4 Fr Lumen Single Central Line, (7) 18 G 4 Fr Single Lumen PICC, (8) 20 G 3 Fr Single Lumen Central Line, (9) 20 G 3 Fr Lumen Single PICC, (10) 24 G 2 Fr Single Lumen PICC. Product number: (1) 97993, (2) 97994, (3) 97901, (4) 97919, (5) 97907, (6) 97922, (7) 97910, (8) 97925, (9) 97913, 10) 97916; all numbered lots are still in the validity period.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Ethicon Endo-Surgery 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
    548
  • Fecha
    2002-03-01
  • 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 sterility of the above procedure tray may be compromised; according to obvious damage to the integrity of the package (example: the package is crooked, crumpled). the manufacturer voluntarily initiated a removal by letter dated november 6, 2001.
  • Acción
    Make sure you received the letter dated November 6, 2001 from Ethicon. Identify and isolate any affected product in your inventory. For more information, contact your local Ethicon representative. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485

Device

BIOVUE Peripherally Inserted Central Catheters (PICC) and Central Line Catheters: (1) No Latex, (...

Manufacturer

Ethicon Endo-Surgery Inc
  • Source
    ANVSANVISA