Events

Retiro De Equipo (Recall) de Device Recall FLEXIGUIDE: SERIES15

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 Alpha Omega Services 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
    49128
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0167-2009
  • Fecha de inicio del evento
    2007-11-15
  • Fecha de publicación del evento
    2008-10-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-12-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72825
  • 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
    Needle - Product Code IWJ
  • Causa
    There is a possibility that the flexiguide needle tip is defective. there is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids.
  • Acción
    Notification of customers initially began November 15, 2007 based on a cursory visual inspection of the defective needle tips. The initial letter advised that there is a possibility that the Flexiguide Needle tip is defective in that there is the potential for the needle's stylet or an HDR source wire/cable to puncture through the defective needle tip during implant or treatment and penetrate the surrounding tissue thereby injuring the patient and/or breaking the sterile boundary. Further distribution and/or use of these products should not take place. The recall notification was updated on November 27,2007 once results from actual testing were available. The letter advises that there is a potential for the needle's tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids. Further distribution and/or use of these products should not take place. Customers are to return the products for credit. A response form is provided. Contact Alpha-Omega Services, Inc. at 1-800-346-7894 for assistance.

Device

Device Recall FLEXIGUIDE: SERIES15
  • Modelo / Serial
    Lots: F02562, F02569, and F02611
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    NV, AZ, CA, MI, UT, MO, CO, and OH
  • Descripción del producto
    Alpha-Omega Services, Inc. Product No: NFV0003-003 || Description: NEEDLE, FLEXIGUIDE: SERIES-15, 20CM, WITH || FEMALE LUER ADAPTOR, SHARP AND STYLET WITH MALE LUER ADAPTOR (HDR); 10/PKG Quantity: 10/PKG L-NFV0003-003. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.
  • Manufacturer
    Alpha Omega Services Inc

Manufacturer

Alpha Omega Services Inc
  • Dirección del fabricante
    Alpha Omega Services Inc, 9156 Rose Street, Bellflower CA 90706-6420
  • Empresa matriz del fabricante (2017)
    Alpha-Omega Services Inc.
  • Source
    USFDA