Events

Retiro De Equipo (Recall) de Device Recall iovera Smart Tip

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 Myoscience 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
    71650
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2201-2015
  • Fecha de inicio del evento
    2015-07-01
  • Fecha de publicación del evento
    2015-07-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138539
  • 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
    Device, surgical, cryogenic - Product Code GXH
  • Causa
    The expiration date on the outer box label and the pouch label for the iovera smart tip product is incorrect. instead of indicating the correct expiration or 2015-12. the labels were incorrectly labeled 2016-05.
  • Acción
    Myoscience sent an Urgent Medical Device Correction letters dated July 1, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are requested to quarantine any affected product at their site. Myoscience will make arrangements to either correct the incorrect expiation date label or remove the product and replace it with correctly labeled product immediately. Question or concerns may be directed to Customers Service at 510-933-1500.

Device

Device Recall iovera Smart Tip
  • Modelo / Serial
    Catalog numbers:STT0412-¿10 and STT0412-¿5;  Lot numbers : 1504021-¿01 and 1505008.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of TX, NY, MD, CO and CA.
  • Descripción del producto
    iovera 155 Smart Tip; || Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) || iovera Smart Tips are individually packaged in Tyvek PET pouches, which are || then packaged into 5 or 10 pack boxes and shipper boxes. || Product Usage: Cyrogenic Surgical Device The myoscience iovera device is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The iovera device is not indicated for treatment of central nervous system tissue
  • Manufacturer
    Myoscience Inc

Manufacturer

Myoscience Inc
  • Dirección del fabricante
    Myoscience Inc, 46400 Fremont Blvd, Fremont CA 94538-6469
  • Empresa matriz del fabricante (2017)
    MyoScience Inc.
  • Source
    USFDA