Alerta De Seguridad para BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube, 13 x 75mm x 2.0mL

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

¿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
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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. 2017-315 voluntary recall of bd vacutainer k2 edta (k2e) 3.6mg blood collection tube, 13 x 75mm x 2.0ml all concerned healthcare professionals, establishments and the general public are hereby advised by the food and drug administration (fda) regarding the voluntary recall of bd vacutainer k2 edta (k2e) (see photos of the product below) distributed by metro drug, inc. bd vacutainer k2 edta (k2e) 3.6mg blood collection tube is used for the collection of venous blood. product name : bd vacutainer k2 edta (k2e) 3.6mg blood collection tubespecifications : 13 x 75mm x 2.0mlcatalog code : 367841lot. no. : 6279849intended use : for the collection of venous bloodpackaging/selling unit : shelf pack of 100 tubes/case of 10 shelf packsregistration no. : dvr – 3711 bd vacutainer k2 edta (k2e) 3.6mg blood collection tube(13 x 75mm x 2.0ml)recall catalog (ref) / lot identification sample    the above-stated medical device products are being voluntary recalled by becton dickinson and company (bd). bd has confirmed that a limited portion of the lot was manufactured with less than the required amount of [email protected] additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery. 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 email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and standards development division of the fda - center for device regulation, radiation health and research at 857-1900 local 8301. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2017-315.Pdf.