Events

Retiro De Equipo (Recall) de Spirotome

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 Cook Medical Incorporated.

¿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
    69417
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0124-2015
  • Fecha de publicación del evento
    2014-10-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130489
  • 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
    Instrument, biopsy - Product Code KNW
  • Causa
    Medinvents, the manufacturer of the spirotome" soft-tissue biopsy needle set distributed by cook medical, has initiated a voluntary recall of these products. the recall has been initiated due to customer complaints that the protective caps were dislodged in the pouch. further investigation disclosed potential dislodging of protective caps on the needle tips on other distributed products.
  • Acción
    On 9/26/2014, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected distributors and institutions Risk Managers/Recall Administration with instructions for returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call Customer Relations at 1-800-457-4500 or 1-812-339-2235.

Device

Spirotome
  • Modelo / Serial
    Model Numbers: SS-08-06; SS-08-10; SS-08-15; SS-10-06; SS-10-10;  SS-10-15; SS-14-06; SS-14-10; SS-14-15.   Lot numbers: P030214C; P020413A; P190813B; P020413B; P030214A; P020413F; P300913A; P020413D; P190813D; P030214B; P020413E; P190813F; P300913B; P020413C; P190813E.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of Arizona, California, Colorado, Hawaii, Iowa, Illinois, Massachusetts, Maryland, Michigan, Missouri, New Mexico, Pennsylvania, Texas, Virginia, Vermont, and Wisconsin, and the countries of AT; BE; CH; CY; CZ; DE; DK; ES; FI; FR; GB; HU; IC; IE; IS; IT; LB; LT; LU; NL; NO; PT; QA; SE; TR; and ZA.
  • Descripción del producto
    Spirotome" Soft-Tissue Biopsy Needle Set. || The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that has been sized to fit through the lumen of the cutting cannula. The Spirotome Biopsy Needle Set is intended for percutaneous acquisition of soft tissue specimens for laboratory analysis.
  • Manufacturer
    Cook Medical Incorporated

Manufacturer

Cook Medical Incorporated
  • Dirección del fabricante
    Cook Medical Incorporated, 400 N Daniels Way, Bloomington IN 47404-9155
  • Empresa matriz del fabricante (2017)
    Cook Group Incorporated
  • Source
    USFDA