Events

Retiro De Equipo (Recall) de Device Recall Centros(TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set

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 Angiodynamics, 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
    49042
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2397-2008
  • Fecha de inicio del evento
    2008-07-07
  • Fecha de publicación del evento
    2008-09-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72578
  • 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
    Implanted Hemodialysis Catheter - Product Code MSD
  • Causa
    The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at the insertion site.
  • Acción
    AngioDynamics sent URGENT MEDICAL DEVICE letters and reply forms to the consignees via Certified Mail on/about 7/10/08. The recall is being conducted to the medical user level. AngioDynamics is requesting the return of all Centros Hemodialysis Catheters in inventory. The following steps should be taken by the consignees: 1. Identify and segregate the recalled product that is in your possession. 2. Complete the enclosed Centros Hemodialysis Catheter Recall Reply Form and fax it to the attention of the Centros Recall Coordinator at 518-798-1360. It is important that even if you do not have any product remaining in your possession that you fill out the attached form noting zero quantity to be returned and fax the form to AngioDynamics. 3. Ship the recalled product(s) to AngioDynamics. Consignees will be credited for the returned products. Credits will only be issued for returned product that is within the scope of the recall. Reference Return Authorization Number ___ on the outside of the shipping box and include a copy of the Centros Recall Reply Form with the return shipment. --- The letters also provide actions to be taken for product(s) in use: ANGIODYNAMICS recommends that physicians continue to follow facility protocols for inserting dialysis catheters and monitoring dialysis catheter patients. It is recommended that physicians consider evaluation of patients with an indwelling Centros catheter to assure the catheter is properly secured. As stated in the product's instructions for use, it is recommended that the catheter be secured/sutured for the entire duration of implantation. If the sutures have been cut, consider re-suturing to maintain proper catheter position. Do not rely on ingrowth of the cuff to maintain proper catheter position. This failure does not affect the function or integrity of the catheter itself and there have no reports of patient injury due to this problem. For questions, concerns, or more detailed instructions on how to

Device

Device Recall Centros(TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set
  • Modelo / Serial
    Lots S08B02, S08B06, S08C01, S08D02, and S08D11
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Centros(TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set (With Cuff 23cm From Tip), Catalog No./REF 10303102. Sterile. Manufactured for AngioDynamics, Inc. MANUFACTURED IN USA. ANGIODYNAMICS, INC. Queensbury, NY USA 12804.
  • Manufacturer
    Angiodynamics, Inc.

Manufacturer

Angiodynamics, Inc.
  • Dirección del fabricante
    Angiodynamics, Inc., 603 Queensbury Avenue, Queensbury NY 12801
  • Empresa matriz del fabricante (2017)
    AngioDynamics Inc
  • Source
    USFDA