Events

Retiro De Equipo (Recall) de Device Recall UniCircuit (W Connector, Adaptor, Y piece)

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 GE Medical Systems, 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
    52605
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1870-2009
  • Fecha de inicio del evento
    2009-06-05
  • Fecha de publicación del evento
    2009-09-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83446
  • 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
    Breathing circuit - Product Code CAI
  • Causa
    Breathing circuit inner tube may separate from the rigid connectors under certain conditions. a separation of the inner tube from the connector may prevent adequate gas flow (o2, n2o and anesthetic agents) to the patient. a separation can also cause co2 re-breathing. this could lead to hypoxia and/or hypercarbia and inadequate anesthesia delivery.
  • Acción
    GE Healthcare sent consignees 6/5/09 an "Urgent Medical Device Correction" letter dated June 5, 2009. The letter was addressed to Health Care Administrator/Risk Manager; Chief of Anesthesia; Director of Clinical Engineering; Risk Manager. The letter described the Safety Issue, Affected Product Details, Safety Instructions (included "Recall Confirmation" form fax to 973-790-4150), Product Correction and Contact Information.

Device

Device Recall UniCircuit (W Connector, Adaptor, Y piece)
  • Modelo / Serial
    This correction pertains to Uni-Circuits from lot# 084812 and later, up to and including lot# 092210
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, AUSTRALIA, DENMARK, FRANCE, ESTONIA, GERMANY, ITALY, JORDAN, NETHERLANDS, NORWAY, SWEDEN, and UNITED ARAB EMIRATES.
  • Descripción del producto
    GE Healthcare, Uni-Circuit Kit, Adult, Disposable, 1.8 m/72 in, REF M1089028, M1087972, M1087975, M1126445, M1127508, M1127509, M1129780, || M1129781, M1130230, M1137805, M1137199, M1145542, M1170604, M1151662, || M1152224, M1158990, M1100486, M1122080, M1126444, M1163003, M1163255 || M1132533, M1133966, M1170051, M1135144, M1139485, M1118627, M1118628, || M1145406, M1147298, M1137811, M1152651, M1160275. pkg of 20 pcs, Latex Free. Breathing circuit for use with anesthesia machine or ventilator.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Dirección del fabricante
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA