Events

Retiro De Equipo (Recall) de Device Recall Devon Supine, Lithotomy and Trendelenburg Positioning Kit

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 LLC.

¿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
    68243
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1997-2014
  • Fecha de inicio del evento
    2014-05-08
  • Fecha de publicación del evento
    2014-07-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127205
  • 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
    Support, patient position - Product Code CCX
  • Causa
    Straps may separate from the foam pad.
  • Acción
    Covidien Sales Representatives notified customers in person by beginning May 8, 2014. The Sales Representative will provided a copy of the Recall letter (attachment 4), and collect any remaining product at the site. The notification and recovery of the product is expected to be complete no later than May 14, 2014.

Device

Device Recall Devon Supine, Lithotomy and Trendelenburg Positioning Kit
  • Modelo / Serial
    14085, 14086, 14092, 14095, 14101, 14106  *The original recall submission listed 14084 and 14094, these were reported by Covidien in error on the original submission.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of NJ, CA, TX, IL, MO, PA, OH, IN, MI, MN, FL, IN, DC, PA, VA, MS, ME, NV, AR, KY, NY, KS, SC
  • Descripción del producto
    Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 || Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Dirección del fabricante
    Covidien LLC, 15 Hampshire Street, Mansfield MA 02048-1113
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • 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