Events

Retiro De Equipo (Recall) de RK Epidural Needle

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 Epimed International, 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
    74018
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0086-2017
  • Fecha de inicio del evento
    2016-04-22
  • Estado del evento
    Terminated
  • 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=145925
  • 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, conduction, anesthetic (w/wo introducer) - Product Code BSP
  • Causa
    There is a possibility that the needles may have the potential to skive a catheters outer coating. if this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.
  • Acción
    On April 22, 2016, Epimed sent an Urgent Medical Device Recall notices and Recall Return Response Forms to their customers via courier service. Customers were advised to examine all inventory and quarantine product subject to recall immediately. Once the product has been quarantined, please complete and return the enclosed response form as soon as possible by fax to: 518-725-0207, Attn: Quality Assurance. In addition, if you find any product that corresponds to the lot numbers given, please contact the Customer Service Department so that Epimed can arrange for replacement/credit (518-725-0209 or 518-514-1891). Further questions, please call (518) 725-0209.

Device

RK Epidural Needle
  • Modelo / Serial
    1) Spectra Lot# GC091702 (Epimed manufacturing lot # 2801501, Sterile Lot # 12157181) 2) Spectra Lot# GC101871 (Epimed manufacturing lot # 3211503, Sterile Lot # 12157445) 3) Spectra Lot# GC101897 (Epimed manufacturing lot # 3161501, Sterile Lot # 12157325)
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : AL, AK, FL, IN, TN & TX
  • Descripción del producto
    15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 || Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
  • Manufacturer
    Epimed International, Inc.

Manufacturer

Epimed International, Inc.
  • Dirección del fabricante
    Epimed International, Inc., 141 Sal Landrio Dr, Crossroads Business Park, Johnstown NY 12095-3835
  • Empresa matriz del fabricante (2017)
    Epimed International Inc
  • Source
    USFDA