Events

Retiro De Equipo (Recall) de Device Recall Power PORTACATH

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 Smiths Medical ASD Inc..

¿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
    79429
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1074-2018
  • Fecha de inicio del evento
    2017-12-04
  • Fecha de publicación del evento
    2018-03-15
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162308
  • 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
    Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Causa
    Certain models and lots of port a cath implantable port kits may have been misassembled. the kits may incorrectly contain a 6fr or 6.5fr size introducer instead of the correct 8.5fr size introducer. the power port a cath ii kit may also contain the incorrect locking collars in addition to the incorrect sized introducer.
  • Acción
    Customers were notified via letter on about 12/04/2017. Instructions include to examine current inventory for affected product, collect and isolate any potentially affected product, determine the total number of potentially affected product in possession and complete and return the Urgent Medical Device Recall Response Form, return any affected product on hand, and notify customers if the affected products were further distributed.

Device

Device Recall Power PORTACATH
  • Modelo / Serial
    a. Item No. 21-4474-24 (Lot No. 87X040, 87X117);  b. Item No. 21-4475-24 (Lot No. 87X044);  c. Item No. 21-4477-24 (Lot No. 87X097);  d. Item No. 21-8466-24 (Lot No. 87X171);  e. Item No. 21-8468-24 (Lot No. 87X172, 87X244, 87X180);  f. Item No. 21-8469-24 (Lot No. 87X151);  g. Item No. 21-8470-24 (Lot No. 87X173, 87X254, 87X194, 87X198, 87X237)
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution. US nationwide including Puerto Rico, Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos.
  • Descripción del producto
    Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: || a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); || b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); || c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); || d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); || e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); || f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); || g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)
  • Manufacturer
    Smiths Medical ASD Inc.

Manufacturer

Smiths Medical ASD Inc.
  • Dirección del fabricante
    Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
  • Empresa matriz del fabricante (2017)
    Smiths Group Plc
  • Source
    USFDA