Events

Retiro De Equipo (Recall) de Device Recall Prostate Seeding Needle for Use with the Mick Applicator

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 Manan Medical Products, 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
    31963
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0922-05
  • Fecha de inicio del evento
    2005-05-03
  • Fecha de publicación del evento
    2005-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-08-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38818
  • 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
    Source, Brachytherapy, Radionuclide - Product Code KXK
  • Causa
    The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures.
  • Acción
    Manan Medical sent recall letters to their bulk needle customers on 5/3/05, informing them of Mick Radio-Nuclear''s recall of their Prostate Seeding Needles manufactured by Manan due to the out of specification needle hub sticking in the applicator. The accounts were informed that the needles manufactured for them were made using the same mold as the Mick needle, and were requested to return the affected lot numbers to Manan for replacement.

Device

Device Recall Prostate Seeding Needle for Use with the Mick Applicator
  • Modelo / Serial
    Part number B0140286, lot numbers 0747, 0839, 0840, 3412, 3413, 3414, 3415, 4078, 4088 and 4089; Part number 2380US-18E-17, lot number 0015
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Florida and Georgia
  • Descripción del producto
    Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded plastic hub. The non-sterile prostate seeding needles were shipped in bulk for packaging, sterilization and distribution by the customers; the bulk packages were labeled as follows: || a) part no. B0140268, Prostate Seeding Set, MICK, InterV - Wheeling, Wheeling, IL 60090 and b) part no. 2380US-18E-17, 18GA x 17CM MK Prostate Seeding Nee, InterV - WHeeling, WHeeling, IL 60090
  • Manufacturer
    Manan Medical Products, Inc.

Manufacturer

Manan Medical Products, Inc.
  • Dirección del fabricante
    Manan Medical Products, Inc., 241 W Palatine Rd, Wheeling IL 60090-5824
  • Source
    USFDA