Events

Alerta De Seguridad para Mobicath Bi-directional Guide Sheath Technical Name: Vascular Catheter Introduction Kit, Airship ANVISA Registration Number: 80145901385 Hazard Class: IV Affected Model: Mobicath - Short Curve and Long Curve Series Affected Numbers: SKU D140010, lots: W3332609 , W3338632, W3338635, W3348351, W3348350, W3338707, W3352503, W3359665, W3363850, W3370052, W3374700, W3374699, W3363851, W3379647, W3379650, W3384700, W3384701, W3390551, W3390549, W3397950, W3407815, W3397877, W3397879, W3407814, W3436355, W3436356 , W3436351, W3436358, W3441735, W3446769, W3441737, W3446767, W3449392, W3451862, W3451863, W3455439, W3455438, W3459354, W3455440, W3462467, W3462470, W3470335, W3470336, W3483637, X3489776, W3493240, W3497507, W3501348, X3497121, X3497510, W3501349 , X3501345, X3514814, X3501344, X3503248, X3507599, X3518116, X3565743, W3581648, X3581652, X3586059, X3592497. SKU D140011, lots: W3330988, W3330990, W3330688, W3338636, W3335354, W33351874, W3361889, W3363852, W3374701, W3379653, W3384702, W3392891, W3436359, W3441739, W3449393, W3451865, W3462471, W3470337, W3479706, X3493675, W3494912, X3497511, X3501245 , W3497509, X3501353, X3501350, W3501354, W3507597, X3507598, X3514815, W3542347, X3537038, X3565745.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Greatbatch Medical.

¿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
    2236
  • Fecha
    2017-03-20
  • 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
    - Examine the inventory and identify the batches affected that the customer has. - Isolate these devices immediately. - Complete the Confirmation Form indicating the number of devices to be returned and send the Form by email to J & J; Brazil.
  • Causa
    Greatbatch medical, the legal manufacturer of the mobicath® bi-directional guiding sheaths (bibicath® bi-directional guiding sheaths), is conducting a global voluntary field removal because of the discovery of a purse sealing integrity problem in specific batches of the guide sheath mobicath® bi-directional and, as a result, may compromise the sterile bag barrier.
  • Acción
    Field Action Code 17000016 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will update, correct or supplement the instructions for use.

Device

Mobicath Bi-directional Guide Sheath Technical Name: Vascular Catheter Introduction Kit, Airship ...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Greatbatch Medical
  • Source
    ANVSANVISA