Events

Retiro De Equipo (Recall) de Daig Livewire Steerable and Supreme Fixed Curve Diagnostic Electrophysiology Catheters

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 Sustainability Solutions.

¿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
    75409
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0380-2017
  • Fecha de inicio del evento
    2016-10-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150221
  • 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, recording, electrode, reprocessed - Product Code NLH
  • Causa
    The ep catheters may be mislabeled for french size during reprocessing.
  • Acción
    The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/6/2016 to its customers. The letter described the product, problem and actions to be taken. Customers were instructed to discontinue use of the recalled product. Other EP Catheters reprocessed by Stryker Sustainability Solutions should be considered as alternatives. To complete and Return the Recall Effectiveness Check Form, even if no affected product is found, to your local Stryker Sustainability Sales Representative or email to SSSPFA@stryker.com or mail to: Stryker Sustainability Solutions 1810 West Drake Drive Tempe, AZ, 85283 Attn: Jodie Rueckert If you have any questions, contact Senior Director RA at 1(888)888-3433.

Device

Daig Livewire Steerable and Supreme Fixed Curve Diagnostic Electrophysiology Catheters
  • Modelo / Serial
    Item Number Serial Number Manufacturing Date 401940 1902898 3/31/2015 401940 1908621 3/31/2015 402004 1902392 1/9/2015 402004 1902389 1/9/2015
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    U.S. distribution to the following; AZ, MN and MO.
  • Descripción del producto
    Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters || Model Numbers: || 401940, 402004 || UPC Code: || 00885825007409 || 00885825007744 || Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. || Reprocessed Diagnostic EP Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Dirección del fabricante
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA