Events

Alerta De Seguridad para CATERING REINTRODUCTION OUTBACK LTD. All Lots. Catalog Number: OTB42120. Anvisa Reg: 80145900965.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Cordis Corporation.

¿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
    938
  • Fecha
    2008-09-02
  • 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
    The manufacturer of the product (Cordis Corporation) has verified that the rate of separation of the cannula of the application slider, in the assembly of the handle in the Catheter of Reintroduction Outback LTD, is larger than the expected one. The potential result of this separation is the impossibility of retracting the cannula needle into the cannula body. The manufacturer has concluded that it will be necessary to carry out a voluntary recall of all batches of the product (code OTB42120) that are on the market. According to a letter of clarification sent by Johnson & Johnson Medical Brasil Ltda to the Anvisa Tecnovigilance Unit (UTVIG), the collection applies to all batches of the product.
  • Causa
    Potential for failure of the reintroduction cannula by retracting into the catheter.
  • Acción
    The actions requested of the user are as follows: (1) Locate, separate and identify immediately all affected products to ensure that they are not used; (2) Complete and return the Recall Confirmation Form to the product registration holder (Johnson & Johnson Medical Brazil Ltda.); (3) Return the products at risk to the record holder, either directly or through local sales representatives; (4) If any product has been shipped to another establishment, please contact us to arrange for the return of the product.

Device

CATERING REINTRODUCTION OUTBACK LTD. All Lots. Catalog Number: OTB42120. Anvisa Reg: 80145900965.

Manufacturer

Cordis Corporation