Events

Retiro De Equipo (Recall) de SPS Blue Line Tube Clamp Adapters

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 Southern Prosthetic Supply Co..

¿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
    36626
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0445-2007
  • Fecha de inicio del evento
    2006-10-03
  • Fecha de publicación del evento
    2007-01-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49024
  • 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
    Tube Clamp adapters - Product Code ISH
  • Causa
    Device fracturing: recent design and process changes leave the device susceptible to fracturing, which could cause the prosthesis to fail.
  • Acción
    On October 6, 2006, SPS faxed a recall notification to the 187 customers who had purchased one or more BL120M Tube Clamp Adapters from SPS between August 29 and September 20, 2006. On October 9, SPS contacted those customers that had purchased five or more Adapters via telephone to confirm they had received the faxed recall notification. On October 10, SPS mailed another copy of the recall notification, via certified mail, return receipt requested to all of its customers that had purchased one or more BL120M Tube Clamp Adapters. The customers were told to send the BL120M Adapter back to SPS following replacement.

Device

SPS Blue Line Tube Clamp Adapters
  • Modelo / Serial
    Product number BL120M, with the letters, ''SPS'' etched into the product
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    SPS Blue Line Tube Clamp Adapters, Product No. BL120M
  • Manufacturer
    Southern Prosthetic Supply Co.

Manufacturer

Southern Prosthetic Supply Co.
  • Dirección del fabricante
    Southern Prosthetic Supply Co., 6025 Shiloh Rd Ste A, Alpharetta GA 30005-1706
  • Source
    USFDA