Events

Alerta De Seguridad para custom procedural trays or kits containing 1% Lidocaine HCl Injection

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

¿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
    2014-02-27
  • Fecha de publicación del evento
    2014-02-27
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140227.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: merit medical systems custom procedural trays or kits containing 1% lidocaine hcl injection the u.S. food and drug administration (fda) posted a medical device safety alert concerning custom procedural trays or kits containing 1% lidocaine hcl injection, usp, 10 mg/ml, lot 25-090-dk. the products were recalled because there was one confirmed customer report where visible particulate were found in the primary product container in the form of dark red/black particles. the particular matter may dislodge through the tissue and could possibly cause a pneumothorax or haemothorax. for details, please refer to the fda website http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-0980-2014&w=02262014&lang=eng if you are in possession of the product, please contact your supplier for necessary actions. posted on 27 february 2014.

Device

custom procedural trays or kits containing 1% Lidocaine HCl Injection

Manufacturer

Merit Medical Systems