Events

Retiro De Equipo (Recall) de Device Recall Stryker PainPump2

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
    51239
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1186-2009
  • Fecha de inicio del evento
    2009-02-11
  • Fecha de publicación del evento
    2009-04-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-12-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79389
  • 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
    An electronic failure during preparation of the unit, or during patient use, may cause the pump to shut down.
  • Acción
    A "Medical Device Recall Notification" letter dated February 11, 2009 was issued to consignees via phone, mail and/or email. The letter described the issue and instructed customers to discontinue use of the recalled product, destroy it according to instructions provided with the notification and return the "Business Reply Form" by fax to Stryker Instruments Regulatory Department, 1-866-521-2762. Further questions should be addressed to Stryker Instruments at 1-800-800-4236 extension 4086.

Device

Device Recall Stryker PainPump2
  • Modelo / Serial
    Lot Numbers: 08239012, 08254012 and 08297012.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA including states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, WA, WI, WV and WY and countries of Argentina, Australia, Brazil, Canada, England, Singapore and South Africa.
  • Descripción del producto
    Stryker PainPump2, 400 mL PainPump with 2.5 inch ExFen 2 Site Catheter Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 540-25. || The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management.
  • 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., Portage MI 49002-9704
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA