Events

Alerta De Seguridad para Isoline 2CR6 Defibrillation Leads (Serial No. S2CR605346 and S2CR605347)

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

¿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
    2011-11-15
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111115d.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
    Health canada type ii recall: sorincrm isoline 2cr6 defibrillation leads (serial no. s2cr605346 and s2cr605347) it has come to our attention that the health canada has issued a type ii recall regarding the sorincrm isoline 2cr6 defibrillation leads (serial no. s2cr605346 and s2cr605347). as stated in the report, a batch of isoline defibrillation leads was labelled with an incorrect use before date (ubd), which was greater than the maximum of 36 months shelf life. the date printed on the labels was 5 may 2013, while the correct ubd is 21 september 2012. according to the supplier, the affected product with serial no. s2cr605346 and s2cr605347 have never been distributed or supplied in hong kong. for details, please refer to the health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_oct-dec_2011-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Isoline 2CR6 Defibrillation Leads (Serial No. S2CR605346 and S2CR605347)
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Sorin CRM Isoline 2CR6 Defibrillation Leads (Serial No. S2CR605346 and S2CR605347)
  • Manufacturer
    Sorin

Manufacturer

Sorin