Events

Retiro De Equipo (Recall) de Device Recall VIA Medical Collection Bag

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 International Biomedical, Ltd..

¿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
    65341
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1531-2013
  • Fecha de inicio del evento
    2013-05-24
  • Fecha de publicación del evento
    2013-06-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118591
  • 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
    pump, infusion, analytical sampling - Product Code LZF
  • Causa
    International biomedical has received reports of interference between the collection bag and the extension set connectors. evaluation of the affected components indicates that the collection bag connector can become occluded due to an over-tightening of the luer lock by the end user. to alleviate the occurrence of this issue in the fixture, the connector on the collection bag has been improved to.
  • Acción
    International Biomedical decided to recall and sent "Product Bulletin" notification letters to their consignees on 05/24/2013 or 05/30/2013. The letter described the product issue and provided customers with recommended actions. Questions were directed to (512) 873-0033.

Device

Device Recall VIA Medical Collection Bag
  • Modelo / Serial
    Model/Part Number: 209-2113, or as part of kits 777-3103 and 777-3102. Collection Bag Lot numbers: 4389, 4465, 4478, 4516, 4530, 4430, 4489
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The collection bag is packaged in a tyvek pouch which is included in either replacement kit (777-3103) or LVM sensor kit (777-3102).
  • Manufacturer
    International Biomedical, Ltd.

Manufacturer

International Biomedical, Ltd.
  • Dirección del fabricante
    International Biomedical, Ltd., 8508 Cross Park Dr, Austin TX 78754-4532
  • Empresa matriz del fabricante (2017)
    International Biomedical, Ltd.
  • Source
    USFDA