Events

Retiro De Equipo (Recall) de Device Recall Epicor LP Connecting Cable, CC6LPCE

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 St. Jude Medical 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
    50521
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0946-2009
  • Fecha de inicio del evento
    2008-12-09
  • Fecha de publicación del evento
    2009-01-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75694
  • 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
    Electrosurgical cutting and coagulation device - Product Code OCL
  • Causa
    Firm has received multiple reports of difficulties connecting the product and/or the presence of error code messages occurring with the use of the connecting cable and the ablation control system unit.
  • Acción
    The firm issued notification by "Urgent Product Recall" letter dated 12/4/2008, to all consignees. The letter describes the issue, potential risk and states that the product should be returned. For additional information, contact St Jude Medical at 800-722-3423.

Device

Device Recall Epicor LP Connecting Cable, CC6LPCE
  • Modelo / Serial
    All serial numbers affected, lot numbers 08051201, 08051504, 08052202, 08062605, 08070702, 08070704, 08071604, 08071801, 08072505, 08072506, 08080119, 08080801, 08082702, 08091112, 08092210, 08092608, 08100202, 08100703, 08101005, 08102006, 08102325, 08102805, 08110530, and 08111412.  ***UPDATE 01/09/2009*** Serial numbers NS-10156, NS-10158, NS-10159, NS-10160 and NS-10161 were originally not included in the original submission. The lot number assigned to prior SN assignment adds 08052901, 08081801, 08091801, 08040701, 08071806, 08101326, and 08103001
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide - NY, IN, NC, UT, OR, CA, IL, MI, TX, TN, and FL and country of Belgium.
  • Descripción del producto
    Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, manufactured by St.Jude Medical, Sunnyvale, CA || Disposable connecting cable, accessory to the Epicor Cardiac Ablation Control System. The cable is used to connect the Epicor disposable tissue device (UltraCinch or UltraWand) to the Epicor Cardiac Ablation control System.
  • Manufacturer
    St. Jude Medical Inc

Manufacturer

St. Jude Medical Inc
  • Dirección del fabricante
    St. Jude Medical Inc, 240 Santa Ana Ct, Sunnyvale CA 94085-4512
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA