Events

Retiro De Equipo (Recall) de Stryker PainPump2 400 mL Painpump with Luer Lock Tubing Set, REF 540-350, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI.

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 Stryker Instruments Div. of Stryker Corporation.

¿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
    Recall
  • ID del evento
    56687
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0097-2011
  • Fecha de inicio del evento
    2010-08-16
  • Fecha de publicación del evento
    2010-10-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94282
  • 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
    Pump, Infusion - Product Code FRN
  • Causa
    The instructions for use (ifu) has been revised for health care professionals. the indication for use has been changed to remove site specific pain management. the firm has revised the warning to not use the pump around joint spaces. a warning has been added regarding the use of the pump with anticoagulants in epidural applications. a special reminder to users to always evaluate the potential.
  • Acción
    Stryker Instruments sent Urgent Medical Device Recall Notification letters dated 8/16/2010 to healthcare professionals. The recall letters outlined the changes for the instructions for the use of these products. The letters informed the healthcare professional to review the new IFU, to distribute the new IFU to all healthcare professionals that use the device, and to complete and return the business reply form. The letters included a complete IFU that was to be used with any remaining stock of devices. Customers should dispose of the old version of the IFU. There is no product being returned for this recall.

Device

Stryker PainPump2 400 mL Painpump with Luer Lock Tubing Set, REF 540-350, Sterile, Rx only, Stry...
  • Modelo / Serial
    09162012, '09163012, '09208012, '09215012, '09223012, '09232012, '09238012, '09246012, '09259012, '09266012, '09280012, '09287012, '09300012, '09303012, '09351012, '09352012, '09353012, '09355022, '09356012, '09362022, '10005012, '10007012, '10008012, '10011012, '10047012, '10048012, '10049012, '10050012, '10074022, '10076012, '10077012, '10078012, '10081022, '10102022, '10103012, '10104012, '10105012, '10106012, '10109022, '10110012, '10111022, '10112032, '10113012, '10116022, '10117012, '10118012, '10119012, '10120012, '10123022, '10124012, '10153012, '10154012 and '10155012.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US, Canada and Australia.
  • Descripción del producto
    Stryker PainPump2 400 mL Painpump with Luer Lock Tubing Set, REF 540-350, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Dirección del fabricante
    Stryker Instruments Div. of Stryker Corporation, 4100 E. Milham Ave., Kalamazoo MI 49001
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA