Events

Retiro De Equipo (Recall) de Device Recall Langston Dual Lumen Catheters

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 Vascular Solutions, 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
    68489
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1981-2014
  • Fecha de inicio del evento
    2014-05-27
  • Fecha de publicación del evento
    2014-07-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128032
  • 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, intravascular, diagnostic - Product Code DQO
  • Causa
    The inner catheter of some langston v2 dual lumen catheters have separated from the device hub during contrast pressure injections. this may require an intervention to retrieve the separated piece from the patient to prevent injury.
  • Acción
    Vascular Solutions sent an Urgent Medical Device Removal letter dated May 23, 2014, to all affected consignees.The letter described the problem and the product affected by the recall. Advised consignees to remove affected devices and place them in a secure area. Requested consignees to fill and return the "VSI Account Inventory Form" to VSI's Customer Service Department by email customerservice@vasc.com or fax 763-656-4251. VSI will replace all returned devices. Customers with questions were advised to contact their local Vascular Solutions Account Manager. For questions regarding this recall call 763-656-4300.

Device

Device Recall Langston Dual Lumen Catheters
  • Modelo / Serial
    Lot Numbers: 569436, 569437, 569962 569963, 569964, 569965, 570177, 570178, 570337, 570338, 570339, 570340, 570341, 570504, 570505, 570506, 570507, 570592, 570593, 570674, 570675, 570744, 570745, 570746, 570836, 570926, 570927, 570928, 570929, 571099, 571100, 571101, 571102, 571103, 571350, 571412, 571413, 571414, 571415, and 571727.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA nationwide including DC and Puerto Rico, AUSTRIA, CANADA, GERMANY, ISRAEL, ITALY, NETHERLANDS, SPAIN, SWEDEN SWITZERLAND, and UNITED KINGDOM.
  • Descripción del producto
    Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.
  • Manufacturer
    Vascular Solutions, Inc.

Manufacturer

Vascular Solutions, Inc.
  • Dirección del fabricante
    Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA