Retiro De Equipo (Recall) de Baxter Clearlink IV Delivery System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Baxter Healthcare Corp..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Set, Administration, Intravascular - Product Code FPA
  • Causa
    Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the clearlink needleless device.
  • Acción
    An Urgent Device Correction letter and reply form dated 4/28/04 were sent to all U.S. Clearlink customers, informing them of the reports of increased infection rates abd describing the revision of the product labeling with additional statements that relate to product usage and reinforcement of standard clinical practices and proper aseptic technique. The revised labeling statements are as follows: * Ensure clamp is open. Swab Luer activated surface with preferred antiseptic prior to first use and before every subsequent connection. * Don not swab Luer activated surface when clamp is closed or valve is recessed. Ineffective swabbibg may result. Replace if valve remains recessed. * Flush Luer activated valve after blood infusion/sampling. If valve cannot be cleared of blood, replace immediately. * Luer lock vacutainer holders, syringes and accessories are recommended for blood sampling. If blood remains on valve surface after sampling, swab surface. * If intermittently disconnecting set from Luer activated valve, immediately cover male Luer with a sterile replacement protector.


  • Modelo / Serial
    all lots of product code 2N8399, 1C8678, 1C8680, 1C8683, 1C8684, 1C8687, 1C8693, 1C8702, 1C8704, 1C8705, 1C8706, 1C8707, 1C8712, 1C8722, 1C8723, 1C8727, 2C0168, 2C6254, 2C6255, 2C6256, 2C7461, 2C7462, 2C8401, 2C8402, 2C8419, 2C8425, 2C8428, 2C8515, 2C8519, 2C8537, 2C8541, 2C8546, 2C8548, 2C8571, 2C8593, 2C8606, 2C8607, 2C8610, 2C8612, 2C8632, 2C8634, 2C8671, 2C8700, 2C8720, 2C8750, 2C8751, 2C8819, 2C8851, 2C8857, 2C8858, 2C8860, 2C8862, 2C8864, 2C8865, 2C8875, 2C8891, 2C8895, 2C8920, 2C8921, 2C8930, 2C8931, 2H7462, 2H7463, 2H8401, 2H8480, 2H8486, 2H8519, 2H8603, 2H8720, 2H8750, 2H8819, 2H8860, 2H8862, 2H8864, 2H8865, 2N8300, 2N8334, 2N8335, 2N8341, 2N8371, 2N8373, 2N8374, 2N8377, 2N8378, 2N9204K, 2N9205K, 3C0122, 3C0134, 3C0139, 3C0143, 3C0148, 3C0150, 3C0151, 3C0157, 3C0158, 3C0159, 3C0160, 3C0162, 3C0165, 4C8714, 4C8723, 4H8723
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide, and internationally through Baxter subsidiaries to Macedonia, Nigeria, Saudi Arabia, South Africa, Ireland, Italy, Denmark, Germany, the Netherlands, Hong Kong, Indonesia, Singapore, Spain, Belgium, Norway, United Kingdom, France and Luxembourg.
  • Descripción del producto
    Baxter Clearlink Intravenous (IV) Delivery System; the system consists of solution sets, extension sets and blood sets that have a luer activated valve for IV access, which allows the administration of medications/solutions with a needleless luer syringe; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
  • Manufacturer


  • Dirección del fabricante
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source