Events

Alerta De Seguridad para COSEAL 4ML and 8ML. Anvisa Registry n ° 80145240375. Affected lots: HA111018 and HA111021.

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

¿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
    1159
  • Fecha
    2012-08-03
  • 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
    According to the company, during waiting for release at customs the product was exposed to temperatures higher than the maximum temperature validated for storage, which may compromise its stability. The field action was initiated on 05/31/2012 by the company and, according to information presented by Baxter to this UTVIG, the end of the product collection is scheduled for October 31, 2012. #### Update (05 / 09/2012): the company sent a Monitoring Report stating that after 60 days of commencement of the communication to customers, of the 56 units sold were consumed 40 units by the customers and 16 units were collected by the company. The company's next action is the destruction of the products collected. #### Update (11/29/2012): According to the field action report presented by the company, the action was closed on 10/31/2012. Fourteen units of the product Coseal 4ml and 2 units of the product Coseal 8ml were collected (71 and 30 units in Brazil, respectively). According to Baxter, all affected customers responded to the company's statement and the units collected were destroyed on 09/05/2012.
  • Causa
    Possibility of loss of effectiveness.
  • Acción
    The company has already started communicating the field action to its customers and the collection of the product is scheduled for the beginning of August 2012. Check in your inventory the existence of products affected by this field action and segregate the products located, identifying them to avoid inadvertent use. Follow the recommendations of Baxter Hospitalar Ltda regarding the return of affected products to the company.

Device

COSEAL 4ML and 8ML. Anvisa Registry n ° 80145240375. Affected lots: HA111018 and HA111021.

Manufacturer

Baxter Hospitalar Ltda
  • Source
    ANVSANVISA