Events

Retiro De Equipo (Recall) de Device Recall LMA Esophageal Intubation Detector (EID), Catalog Number EID100

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 LMA North America 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
    62337
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2022-2012
  • Fecha de inicio del evento
    2012-05-23
  • Fecha de publicación del evento
    2012-07-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110279
  • 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
    Tube, tracheal (w/wo connector) - Product Code BTR
  • Causa
    The recall was initiated because lmana has received a complaint that the esophageal intubation detector (eid100) has a potential to create a false positive if used on a patient during confirmation of intubation.
  • Acción
    LMA North America Inc. sent a recall letter dated May 23, 2012, for US customers, and May 24, 2012, for International customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to fill out the bottom portion of the recall letter and promptly fax it back to LMA North America at (858) 622-4130. If customers have units of EID100 from the affected lots remaining in stock, customers were instructed to arrange for immediate return by contacting LMANA's customer service department at (800) 788-7999, menu selection #2. For further questions please contact Customer Service Representative at (800) 788-7999.

Device

Device Recall LMA Esophageal Intubation Detector (EID), Catalog Number EID100
  • Modelo / Serial
    2009 Lot # 90923A, 91222A. 2010 Lot# 00327A, 00518A, 00623A, 00831B, 01013A, 01103A, 01214A.  2011 Lot# 10110A, 10301B, 10423A, 10530A, 10602A, 10703A, 10804A, 11004A. 2012 Lot# 120104, 120414.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia.
  • Descripción del producto
    LMA Esophageal Intubation Detector (EID), Catalog Number EID100 || The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment
  • Manufacturer
    LMA North America Inc

Manufacturer

LMA North America Inc
  • Dirección del fabricante
    LMA North America Inc, 4660 La Jolla Village Dr Ste 900, San Diego CA 92122-4608
  • Empresa matriz del fabricante (2017)
    Lma North America, Incorporated
  • Source
    USFDA