Events

Alerta De Seguridad para Multi-Med Single Lumen Catheters

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

¿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
    2016-12-12
  • Fecha de publicación del evento
    2016-12-12
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161212a.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: centurion multi-med single lumen catheters the united states food and drug administration (fda) has issued medical device safety alerts concerning multi-med single lumen catheters manufactured by centurion. the affected devices are identified as follows:- product code: foz centurion kit codes: ecvc1680, ecvc4785, m11620hkic, m11620hkicnl, m11620hs, m11620kc, m11620kcnl, m12013k, m12013knl lot numbers: 2016062150, 2016062950, 2016070650, 2016081550, 2016051050 2016053150, 2016060750, 2016061550, 2016063050, 2016072050, 2016080250, 2016091950, 2016060750, 2016072650, 2016093050, 2016101050, 2016052050, 2016062850, 2016082350, 2016082650, 2016090250, 2016050950, 2016053150, 2016060750, 2016071250, 2016080350, 2016082950, 2016060850, 2016061650, 2016062050, 2016070550, 2016071950, 2016080250, 2016090750, 2016071350, 2016072050, 2016092650, 2016100650, 2016072950, 2016082450 distribution date: 23 may 2016 to 18 oct 2016 the manufacturer is recalling the centurion convenience kits containing multi-med single lumen catheters. the catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process. if this occurs, the excess material may separate from the catheter during use and could enter the patient’s bloodstream. this can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death. customers are asked to identify and stop using the affected products in their inventory. for details, please refer to the fda website: medwatch: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm532629.Htm medical device recalls:http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm532576.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 december 2016.

Device

Multi-Med Single Lumen Catheters

Manufacturer

Centurion