Events

Alerta De Seguridad para Merit 1mL Medallion Syringes

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
    2018-03-05
  • Fecha de publicación del evento
    2018-03-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180305.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 1ml medallion syringes medical device manufacturer, merit medical systems, inc., has issued a medical device safety alert concerning its 1ml medallion syringes. the affected products are identified as below: catalog numbers: a) k01-05526p; b) k01-07427; c) k01-07477p; d) k01-07930p; e) k02-00565c; f) k02-01260b; g) k02-01331a; h) k04-00748; i) k12-03636; j) mss011; k) mss011-dg; l) mss011-lg; m) mss011-pr; n) mss011-r; o) mss011-y; p) mss011-yp. lot numbers: a) h1258821; b) h1263015; c) h1242962, h1246807; d) h1246733; e) h1258361; f) h1258575, h1265248; g) h1252652; h) h1258488, h1264381; i) h1258530; j) h1242750, h1246807, h1255504; k) h1246809; l) h1246810; m) h1242752; n) h1242752, h1255507; o) h1246811; p) h1242927. the manufacturer is voluntarily conducting a recall of specific lots of 1 ml medallion syringes due to a supplier manufacturing defect with the syringe plunger tip. according to the manufacturer, prior to use and during prep, when fluid is drawn into the syringe, air may enter the barrel and/or fluid may leak out the back of the barrel. this may result in a minor delay in procedure and user dissatisfaction. it has not received any reports of patient harm or injury as a result of this issue. the manufacturer has chosen to remove the units from the market. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 march 2018.

Device

Merit 1mL Medallion Syringes
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Merit 1mL Medallion Syringes
  • Manufacturer
    Merit Medical Systems

Manufacturer

Merit Medical Systems