Events

Alerta De Seguridad para Sponge, Gauze: 2 x 2 inches 4-folds (1) MIRASORB, (2) NU GAUZE General use. Product Codes: (1) 602318, (2) 2338; Lots No (1) 2001 10 1 to 2001 10 3, (2) 2001 10 10 to 2001 10 3, 2001 10 A to 2001 10 D; units distributed during October 2001.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson 740 Johnson Medical Inc A Division of Ethicon.

¿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
    403
  • Fecha
    2002-02-22
  • 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
    Some of the above gauze packets are improperly packed, which can potentially result in loss of sterility. due to the potential lack of integrity of the package, the manufacturer voluntarily initiated the correction by letter dated 26 october 2001 and on 10 december 2001.
  • Acción
    Please verify that you have received the letter dated October 26, 2001 and December 10, 2001, UPS Shipping / Receiving Card. Identify and remove any product with the batch number above your inventory. Complete the pre-posted response card, attach the card with the affected product, and ship the product to Johnson 751 Johnson. You can receive credit for all returned material or receive product replacement by checking the appropriate line on the prepaid return / remittance card. For incomplete boxes, only credit may be requested. If you do not have any affected products, check the appropriate line on the prepaid shipping / return card, and return the card to Johnson 751 Johnson by mail at the address below, or fax to (1903) 891-6188. For more information, or to receive extra shipping labels, contact Johnson 751 Johnson or your local representative. For more information, contact the ANVISA Technovigilance Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485

Device

Sponge, Gauze: 2 x 2 inches 4-folds (1) MIRASORB, (2) NU GAUZE General use. Product Codes: (1) 60...

Manufacturer

Johnson 740 Johnson Medical Inc A Division of Ethicon
  • Source
    ANVSANVISA