Events

Retiro De Equipo (Recall) de Device Recall Drainer(R) Centesis 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
    80135
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2249-2018
  • Fecha de inicio del evento
    2018-05-04
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164661
  • 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
    Accessories, catheter - Product Code KGZ
  • Causa
    The supplier of drainer(r) centesis catheters notified vascular solutions, inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins.
  • Acción
    Galt Medical Corp. sent an Urgent Medical Device Recall dated May 2, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. The firm requested the following actions be taken: Those with affected stock, were directed to immediately discontinue use and quarantine any product. If the affected product was further distributed, the distributor was directed to immediately contact all parties who may have received the affected stock and recover any unused product. For questions contact your local sales representative or Recall Coordinator at 214-778-1306 or email quality@galtneedletech.com

Device

Device Recall Drainer(R) Centesis Catheters
  • Modelo / Serial
    a) REF 8810, 5F x 9cm, Lot Numbers: 18037128, 18057123 (b) REF 8811, 6F x 9cm, Lot Numbers: 18026062, 18026063 (c) REF 8812, 5F x 15cm, Lot Number: 18050076
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Drainer(R) Centesis Catheters: || (a) REF 8810, 5F x 9cm || (b) REF 8811, 6F x 9cm || (c) REF 8812, 5F x 15cm || Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.
  • 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