Events

Alerta De Seguridad para CrystalR Metal Disposable Blades (Mac 3 and Mac 4)

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

¿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
    2011-09-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110923.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
    Urgent field safety notice: penlon crystalr metal disposable blades (mac 3 and mac 4) medical device manufacturer, penlon ltd., has issued an urgent field safety notice concerning crystalr metal disposable blade (mac 3 and mac 4). penlon has been made aware of an incident where mac 3 blades have been incorrectly packaged in disposable bags labeled as mac 4 and then packed in a carton stating size mac 4. the affected batches have been identified and penlon has determined that this poses a low risk to the users, as users will recognise that the blade is not the size stated on the disposable bag prior to use or during pre-use check. the manufacturer further advised that all theatre staff and stores personnel should check their stock with expiry dates between august 2010 and august 2015 and ensure that the sizes etched on the blades, inner plastic bags, and the carton all match. according to penlon, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

CrystalR Metal Disposable Blades (Mac 3 and Mac 4)
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Penlon CrystalR Metal Disposable Blades (Mac 3 and Mac 4)
  • Manufacturer
    Penlon Ltd.

Manufacturer

Penlon Ltd.