Events

Alerta De Seguridad para VACUETTE Safety Blood Collection Sets and Blood Collection Sets

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Greiner Bio-One.

¿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
  • Fecha
    2013-04-02
  • Fecha de publicación del evento
    2013-04-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130402.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: greiner bio-one vacuette safety blood collection sets and blood collection sets medical device manufacturer, greiner bio-one, has issued a medical device safety alert concerning vacuette safety blood collection sets and blood collection sets. according to the manufacturer, the vacuette safety blood collection set and accessory may display leaking during use due to a crack on the luer connector piece. due to claim from france and due to a supplier’s notification after a supplier audit, greiner bio-one decided to recall some products from the market. the manufacturer estimates the risk for the user as being low. the root cause of the defect is attributed to the fact that the connectors of the defective lot have not been annealed. this non-annealing could brittle the connector and may lead to a crack in the connector. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 2 april 2013.

Device

VACUETTE Safety Blood Collection Sets and Blood Collection Sets
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Greiner Bio-One VACUETTE Safety Blood Collection Sets and Blood Collection Sets
  • Manufacturer
    Greiner Bio-One

Manufacturer

Greiner Bio-One