Events

Retiro De Equipo (Recall) de Device Recall Ventlabassembled Anesthesia breathing bags

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 Ventlab Corporation.

¿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
    48958
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2324-2008
  • Fecha de inicio del evento
    2007-12-05
  • Fecha de publicación del evento
    2008-09-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72404
  • 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
    Reservoir bag - Product Code BTC
  • Causa
    During setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly.
  • Acción
    Medline Industries, Waukegan, IL was notified by letter titled URGENT - MEDICAL DEVICE RECALL on/about 12/05/2007. They were instructed to check their facility for any of the the affected product in inventory. If found they were advised to destroy and discard. They were to notify Ventlab of the disposition of the bags at their facility. Contact James Cochie at 336-753-5000 if you have questions.

Device

Device Recall Ventlabassembled Anesthesia breathing bags
  • Modelo / Serial
    (NC Facility): Part #720057B (3 Liter bags), Lot #63069, 64872, 65226, 66781, 67068, 67068; Part #720058B (2 Liter bags), Lot#63660, 64877, 65225, 68752; Part #720059B (1Liter bags), Lot#63661, 64878, 65227. (China Facility): Part #720057B, Lot #3B0001, 3B0002, 3B0005, 3B0004, 3B0005; Part #720059B, Lot #1B0001, 1B0002, 1B0003; and Part #720058B, Lot #2B0002
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    IL
  • Descripción del producto
    Ventlab-assembled Anesthesia breathing bags. The recall involves 3 Liter, 2 Liter and 1 Liter latex free bags used with Medline anesthesia circuit kits. The bags are sold in bulk.
  • Manufacturer
    Ventlab Corporation

Manufacturer

Ventlab Corporation
  • Dirección del fabricante
    Ventlab Corporation, 155 Boyce Dr, Mocksville NC 27028-4187
  • Source
    USFDA