Events

Alerta De Seguridad para Radius Loop Electrode Box of 5

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

¿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
    2014-10-31
  • Fecha de publicación del evento
    2014-10-31
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141031.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: coopersurgical radius loop electrode box of 5 medical device manufacturer, coopersurgical, has issued a field safety notice concerning its radius loop electrode box of 5. the affected part number is r2010 and lot number is 159621. the product may have been packaged with an incorrectly labeled package type (radius loop electrode p/n r1010). the affected product is a single-use sterile disposable device. the product package contains 5 individually sealed pouches consisting of clear plastic front and a tyvek lid back. the device lot number and expiration date is located on the tyvek lid as well as on the side of the external packaging. according to the manufacturer’s health hazard evaluation report, the potential hazard situation associated with the nonconformance is minimal and no adverse events or injuries have been reported to date in connection with the use of the affected product. the manufacturer advises customers to return the affected products to them and product replacement can be arranged. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 october 2014.

Device

Radius Loop Electrode Box of 5
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: CooperSurgical Radius Loop Electrode Box of 5
  • Manufacturer
    CooperSurgical

Manufacturer

CooperSurgical