Events

Retiro De Equipo (Recall) de Device Recall Guardian II Hemostasis Valve

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
    73553
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1275-2016
  • Fecha de inicio del evento
    2016-03-04
  • Fecha de publicación del evento
    2016-04-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144454
  • 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
    Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
  • Causa
    Vascular solutions became aware of a potential problem with the click version of the guardian ii hemostasis valves. the low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism.
  • Acción
    Consignees were sent on 3/4/2016 via first class mail a Vascular Solutions "Urgent Medical Device Recall" letter dated March 3, 2016. The letter described the problem and the product involved in the recall. It included the "Immediate Action Required of Customer / User" which instructed the customer to identify the product, remove it from inventory, place it in a secure area, and complete and return the VSI Account Inventory Form to the Customer Service Department.

Device

Device Recall Guardian II Hemostasis Valve
  • Modelo / Serial
    Lot numbers: 41776, 41777, 41874, 42108, 42525, 581766, 581767, 583285, and 583286.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution in the states of AL, AR, CA, CO, DE, FL, GA, ID, IL IN, IA,KY, LA, MD, MA, MI, MO, NE,NV, NH, NY, NC, OH, PA, SD, TN, TX, UT, VA, WA, and WV. OUS: Ireland
  • Descripción del producto
    Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. || Product Usage: The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system. The devices have two seals: the low-pressure seal, and the high-pressure seal. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and allows for pressure injections up to 600 psi.
  • 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