Events

Alerta De Seguridad para Stay Safe Disinfection Cap

Según Food and Drug Administration Philippines, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Philippines que fue producido por Fresenius Medical Care Philippines, Inc. .

¿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
    2018-213
  • 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/514738-fda-advisory-no-2018-213
  • 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. 2018-213 voluntary recall of stay safe disinfection cap with batch number z1z04300 the food and drug administration (fda) informs the public and all concerned healthcare professionals that fresenius medical care philippines, inc. has voluntarily recalled the stay safe disinfection cap with batch number z1z04300. it has been discovered that this batch number was distributed without local label sticker. the application stickers for the mentioned batch was missed by their sub-distributor. appropriate corrective and preventive actions will be instituted to prevent recurrence.  as a mitigating measure they will provide replacement of the said medical device product to the affected customers to ensure continuity of care. distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said affected medical device product. for more information and inquiries, please e-mail us at cdrrhr_prsddthis email address is being protected from spambots. you need javascript enabled to view it. . or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.   attachments: fda advisory no. 2018-213.Pdf.

Device

Stay Safe Disinfection Cap

Manufacturer

Fresenius Medical Care Philippines, Inc.