Events

Retiro De Equipo (Recall) de Device Recall MedStream Programmable Infusion Pump

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 Codman & Shurtleff, 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
    67921
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1571-2014
  • Fecha de inicio del evento
    2015-11-10
  • Fecha de publicación del evento
    2014-05-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-11-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126613
  • 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, implanted, programmable - Product Code LKK
  • Causa
    A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
  • Acción
    Codman Neuro sent an Urgent Field Safety Notice to all affected customers on April 18, 2014. The letter identified the product the problem and the action needed to be taken by the customer. The letter states the reason for recall, information about managing patients with affected pumps, and returning affected non-implanted pumps. You are receiving this voluntary recall notification because our records indicate that you are the recipient of one or more MedStream Pumps affected by this recall. Please do not implant any identified products included in this recall. Please complete the enclosed Acknowledgement Form and fax the completed form to: 001-508-977-6665. It is important that we receive this acknowledgement form, even if you have no affected product in your inventory. You may also e-mail the form to us at Codmanproductcomplaints@dpyus.jnj.com We request that you immediately check all inventory to determine if you have affected product. Please contact your Codman Neuro sales consultant to assist you in the return process. Please use the included instructions to report your inventory status and return affected product. Note this recall applies only to

Device

Device Recall MedStream Programmable Infusion Pump
  • Modelo / Serial
    Serial Numbers: NNBLTL, NNBLT5, NNBLR9, NNBLT2, NNBLJP, NNBLL2, NNBLJR, NNBLLH, NNBLLJ, NNBLLG, NNBLT0, NNBLT1, NNBLL7, NNBLTC, NNBLTN, NNBLTK, NPBLZ7, NPBLZH, NPBLZP, NPBLZN, NPBLZM, NPBLZK, NPBLZ4, NPBLZJ, NPBLY3, NPBLY5, NPBLY4, NPBLY7, NPBLZT, NPBLY9, NPBLZR, NPBL7M, NPBL74, NPBMFN, NPBMF0, NPBMHJ, NPBMHK, NPBL71 NPBL9H, NNBLLP, NNBLLN, NNBLLC, NNBLLD, NNBLL3, NPBL0F, NNBLTH,  NPBL6N, NPBL6M, NPBL6L, NPBL1T, NPBL17, NPBL1Y, NPBL1W, NPBL75,  NPBL70, NPBL76, NNBLG2, NPBMFG, NPBMF4, NPBMF2, NPBMF1, NPBMF5,  NPBMH2, NPBMH0, NNBLJM, NNBLJK, NNBLJN, NNBLHZ, NNBLHW, NNBLH2, NNBLH1, NNBLH0, NNBLTB, NNBLL4, NPBL1R, NPBL1P, NPBL1N,  NPBL1L, NPBL1J, NPBL9N, NPBL9K, NPBL9L, NNBLHN, NNBLGV, NNBLHT,  NNBLHM, NNBLG0, NNBLLK, NMBKBW, NMBJ5G
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.
  • Descripción del producto
    MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 || The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
  • Manufacturer
    Codman & Shurtleff, Inc.

Manufacturer

Codman & Shurtleff, Inc.
  • Dirección del fabricante
    Codman & Shurtleff, Inc., 325 Paramount Drive, Raynham MA 02767
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA