Events

Alerta De Seguridad para BioGlue Surgical Adhesive 5mL

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

¿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
    2014-06-13
  • Fecha de publicación del evento
    2014-06-13
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140613a.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: cryolife bioglue surgical adhesive 5ml medical device manufacturer, cryolife has issued a field safety notice concerning its bioglue surgical adhesive 5ml (product code: bg3515-5). at the request of the united states food and drug administration, the manufacturer has changed the expiration dating for the product from 24 months to 18 months due to the fact that the serum albumin component monomer failed to meet the manufacturer’s internally established end of shelf-life specification. based on the manufacturer’s health risk assessment, serum albumin monomer content below specification does not impose any change in patient risk to the delivered product. the manufacturer has advised users in the united states to either return or re-label the affected products. according to the local supplier, integmed ltd., 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 13 june 2014.

Device

BioGlue Surgical Adhesive 5mL
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: CryoLife BioGlue Surgical Adhesive 5mL
  • Manufacturer
    CryoLife

Manufacturer

CryoLife