Events

Retiro De Equipo (Recall) de 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
    56709
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2608-2010
  • Fecha de inicio del evento
    2010-09-02
  • Fecha de publicación del evento
    2010-09-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94333
  • 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
    Investigation of a recent device experience report has made us aware of a potential problem with our 6f langston dual lumen pigtail catheter (model 5540) with the following lot numbers: 548110, 548227, 548364, 548430, 548554 & 548723. recently, it was reported that pouches containing langston pigtail catheter (model 5540) were missing a seal, posing a risk of product contamination. it is possib.
  • Acción
    Consignees were sent on 9/2/10, a Vascular Solutions "Urgent Medical Device Field Action" letter dated September 1, 2010. The letter was addressed to Cath Lab Manager. The letter descried the product and the problem. Provided instructions to examine pouches of opened boxes to see if they have not been sealed. If unsealed, they recommended to remove pouches from the current inventory. For unopened boxes they recommended to remove the boxes from the inventory. Requested consignees to complete the Field Action Customer Inventory Form included with the letter. For any questions, please contact the firm at 763-656-6032.

Device

Langston Dual Lumen Catheters
  • Modelo / Serial
    Lot 548110, 548227, 548364, 548430, 548554, and 548723.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS,MO, NE, NY,NH, NJ, NM, NY,NC, OH, OK, OR, A, PR, SC, TN, TX, UT, VA, WA, WV, WI, and WY. SINGAPORE, MEXICO, CANADA, SPAIN, AUSTRIA, GERMANY, ITALY, ENGLAND, and SWITZERLAND.
  • Descripción del producto
    Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, Vascular Solutions, Inc, 6464 Sycamore Court, Minneapolis, MN 55369, 110 cm length, || Usage: Indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites, This type of pressure measurement is useful in determining transvalvular, intravascular and interventricular pressure gradients.
  • Manufacturer
    Vascular Solutions, Inc.

Manufacturer

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