Events

Alerta De Seguridad para Product name: Leukocyte removal filter for laboratory use Technical Name: Leukocyte Removal Filter (Laboratory) ANVISA Registration Number: 10154450112 Hazard Class: III Model Affected: COMPOSTOP Serial numbers affected: 71KE05GA00, 71KE10GA00 , 71KE25GC00 and 71KG07GA00

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Fresenius Hemocare Brasil LTDA; Fresenius Hemocare Brasil 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
    2318
  • Fecha
    2017-06-23
  • 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
    Disregard the phrase "Special lot - exclusive use for carrying out analysis (Prohibited for human use)" contained on the label. The product can be used normally.
  • Causa
    The company has identified that the product has been labeled with an improper label. this label is used in internal lots for validation purposes and therefore contains the phrase "special lot - exclusive use for analysis (prohibited for human use)", however, due to an operational failure, some commercial lots were labeled with this label. it should be emphasized that the products are fully compliant and ready to be marketed and can be used normally. after internal investigations, it was possible to show that this deviation was due to an operational failure during the label layout review process. all corrective and preventive actions have already been duly implemented by the company, in order to remedy such deviation.
  • Acción
    Field Action Code 02-2017 triggered under the responsibility of the company Fresenius Hemocare Brasil LTDA. Company will report that there is an improper phrase on the product label.

Device

Product name: Leukocyte removal filter for laboratory use Technical Name: Leukocyte Removal Filte...

Manufacturer

Fresenius Hemocare Brasil LTDA; Fresenius Hemocare Brasil LTDA