Events

Alerta De Seguridad para AV-Set B DT INF-E Blood Tubing System

Según Food and Drug Administration Philippines, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Philippines que fue producido por N/A.

¿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
  • Número del evento
    2018-240
  • País del evento
    Philippines
  • Fuente del evento
    FDAP
  • URL de la fuente del evento
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/525285-fda-advisory-no-2018-240
  • Notas / Alertas
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 recall data from the U.S. and Philippines.
  • Notas adicionales en la data
  • Causa
    Fda advisory no. 2018-240 termination of the voluntary recall of  av-set b dt inf-e blood tubing system with dvr no. 8574 (article no. ap16641) the food and drug administration (fda) informs the public that fresenius medical care philippines, inc., marketing authorization holder (mah), has reported that it has completed the recall and removal of av-set b dt inf-e blood tubing system (see figures 1 and 2) with dvr no. 8574 (article no. ap16641) from the philippine market. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2018-240.Pdf.

Device

AV-Set B DT INF-E Blood Tubing System
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP