Events

Retiro De Equipo (Recall) de FIRMap 60mm 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 Abbott Electrophysiology.

¿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
    71970
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2478-2015
  • Fecha de inicio del evento
    2015-08-12
  • Fecha de publicación del evento
    2015-08-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139471
  • 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,intracardiac mapping,high-density array - Product Code MTD
  • Causa
    The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. the manufacturing date was accidentally used (copied) for the expiration date.
  • Acción
    The firm, Abbott Electrophysiology, sent an "URGENT PRODUCT RECALL" letter dated August 11, 2015. A customer recall notification letter was distributed to firm representatives who will visit each consignee and inspect inventory for affected product. Letters were provided to reps on August 12, 2015. The letter describes the product, problem and actions to be taken. The customers were informed that the product they have in stock will be return to the firm and will be provided a replacement product free of charge. If you have any questions, contact Quality Director at 650-681-1744.

Device

FIRMap 60mm Catheter
  • Modelo / Serial
    Model number : USAR064060; Lot code: TPR031615-01
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution in states of: KY, IN, MO, NY, OH, TX, LA, IL, PA, NJ, WA, VA, FL, GA, CT, CA, AZ, CO, and TN.
  • Descripción del producto
    FIRMap 60mm Catheter; || Size: 60 mm; Length 50.4 inches || French Size Diameter: 8.5F (2.84mm) || Model number : USAR064060 || Sterile, Rx only || Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
  • Manufacturer
    Abbott Electrophysiology

Manufacturer

Abbott Electrophysiology
  • Dirección del fabricante
    Abbott Electrophysiology, 1530 Obrien Dr, Menlo Park CA 94025-1454
  • 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