Retiro De Equipo (Recall) de PALINDROME EMERALD Cuffed Dual Lumen Catheter

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 Covidien.

¿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
    50081
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0408-2009
  • Fecha de inicio del evento
    2008-09-19
  • Fecha de publicación del evento
    2008-12-04
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2008-12-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    catheter, hemodialysis, implanted, coated - Product Code NYU
  • Causa
    Incorrect size of the venetrac stylets (an optional accessory). they are too short and cannot be used.
  • Acción
    Starting on 9/19/08, Covidien Sales Representatives visited each of the hospitals that received the catheters, informed the staff that the Venetrac insertion stylets were too short, and placed pink corrective sticker labels on any unused product. Should you require additional information, please contact jim.welsh@covidien.com or 508-216-8532.

Device

  • Modelo / Serial
    Product code/REF Number 8888123411; Lot No: 809403 and 811762
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution including states of OH, WI, LA, TX, UT, CA, OR, and WA.
  • Descripción del producto
    PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888123411, Size 14.5Fr/Ch (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Covidien, 5439 State Route 40, Argyle NY 12809-3830
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA