Events

Retiro De Equipo (Recall) de 17G Cryoablation Needle Holder

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 Galil Medical, 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
    61657
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1613-2012
  • Fecha de inicio del evento
    2012-04-12
  • Fecha de publicación del evento
    2012-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108652
  • 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
    Unit, cryosurgical, accessories - Product Code GEH
  • Causa
    Galil medical is recalling 17g cryoablation needle holder, fprpr 4014. this voluntary recall has been initiated due to the possibility of excessive bioburden on the needle holders.
  • Acción
    Galil Medical sent an "Urgent Medical Device Recall" letter dated April 12, 2012 to all affected customers. The letter identified the affected product, problem, actions to be taken. The letter instructs customers to return all unused affected products, use a revised needle preparation procedure and forward and communicate this Recall Notice and instructions. Customers were instructed to complete and return the attached Response Form with returned product or fax to 1+877-510-7757. For any questions contact Galil Medical Customer Service.

Device

17G Cryoablation Needle Holder
  • Modelo / Serial
    N8185-001; N9438-001; N9438-003; N9438-004; N7890-003; N7975-001; N7975-002; N8185-006; N8185-007; N7729-005; N7890-004; N9438-002; N8185-005; N8185-008; N7890-005; N7975-003; N7729-001; N7729-002; N8185-009; N8185-010; N7729-003; N7729-004; N7890-001; N7890-002 ; N7975-004;N7975-005
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including the states of CA, NY, NC, WA and the countries of CANADA, DENMARK, FRANCE, NETHERLANDS, TAIWAN and UNITED KINGDOM.
  • Descripción del producto
    Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO. || Product Usage: || Galil Medicals 17G Cryoablation Needle Holder (Needle Holder) is intended for use only with a Galil Medical Needle Testing Device (NTD). The NTD, a component used when performing cryogenic destruction of tissue with a Galil Medical Cryoablation System, is intended for performing a Needle Integrity and Functionality Test in preparation for a cryoablation procedure, and also serves to organize and support the cryoablation needles and thermal sensors in a sterile environment, prior to use.
  • Manufacturer
    Galil Medical, Inc.

Manufacturer

Galil Medical, Inc.
  • Dirección del fabricante
    Galil Medical, Inc., 4364 Round Lake Rd W, Arden Hills MN 55112
  • Empresa matriz del fabricante (2017)
    Btg Plc
  • Source
    USFDA