Events

Retiro De Equipo (Recall) de Device Recall Mick TP Prostate Seeding 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 Mick Radio Nuclear Instr 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
    32046
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0857-05
  • Fecha de inicio del evento
    2005-03-30
  • Fecha de publicación del evento
    2005-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39007
  • 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, Isotope, Gold, Titanium, Platinum - Product Code IWF
  • Causa
    Some of the mick tp prostate seeding needles do not fit properly into the mick 200-tpv applicator. firm received one complaint during use of the mick 200 tpv applicator.
  • Acción
    Recall Notices (dated 3/30/05) were sent to the consignees by First Class Mail on 3/30/05. Follow-up phone calls to the consignees were initiated on 4/22/05. Recall was expanded for 7 additional lots, and recall notices (dated 8/09/05) were sent to the direct consignees (medical facilities).

Device

Device Recall Mick TP Prostate Seeding Needle
  • Modelo / Serial
    Lots: M121504-07 (Exp. 12/15/09), M012605-01 (Exp. 1/26/10), M012805-01 (Exp. 1/28/10); --- 8/09/05 RECALL EXPANSION (7 Lots): M110204-01 (Exp. 11/02/09), M110204-04 (Exp. 11/02/09), M110504-02 (Exp. 11/05/09), M120804-01 (Exp. 12/08/09), M120904-01 (Exp. 12/09/09), M121004-03 (Exp. 12/10/09), M121404-01 (Exp. 12/14/09)
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Medical facilities located nationwide, and distributors in Sweden, The Netherlands, Germany and the United Kingdom.
  • Descripción del producto
    Mick TP Prostate Seeding Needles, 18 Gauge, Catalog/Model Number MTP-1820-C. --- BRAND NAME: Mick TP Disposable Needle 18 Gauge. COMMON/USUAL NAME: TP Needle 18 Gauge. CLASSIFICATION NAME: System, Applicator, Radionuclide, Manual. --- The needle is an accessory to the Mick 200-TPV Applicator and Kit. This one time use needle is used for brachytherapy. The product is sold in cartons with each carton containing a total of 25 needles. Each carton contains 4 packages of 5 needles, and 5 packages containing one needle each.
  • Manufacturer
    Mick Radio Nuclear Instr Inc

Manufacturer

Mick Radio Nuclear Instr Inc
  • Dirección del fabricante
    Mick Radio Nuclear Instr Inc, 521 Homestead Avenue, Mount Vernon NY 10550-4619
  • Source
    USFDA