Events

Alerta De Seguridad para Teleflex Medical CAPIO Sutures

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

¿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
    2014-03-19
  • Fecha de publicación del evento
    2014-03-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140319b.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: boston scientific teleflex medical capio sutures medical device distributor, boston scientific, has issued a medical device safety alert concerning teleflex medical capio sutures at the request of the manufacturer, teleflex medical. the catalogue numbers of the affected products include: 833-114, 833-123, 833-124, 833-136, 833-137, 833-213. according to the manufacturer, certain lots of the products did not meet minimum needle attachment strength, knot tensile strength, minimum diameter, or minimum resorption strength requirements. this may result in suture breakage, delay in procedure, wound dehiscence, or the need of additional surgical intervention. the manufacturer will recall all affected products. according to the local supplier, the affected products were not distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 march 2014.

Device

Teleflex Medical CAPIO Sutures

Manufacturer

Boston Scientific / Teleflex Medical