Events

Retiro De Equipo (Recall) de Device Recall Odyssey

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 KooJoo Trading Company.

¿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
    65664
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1729-2013
  • Fecha de inicio del evento
    2013-07-03
  • Fecha de publicación del evento
    2013-07-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119830
  • 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
    Lancet, blood - Product Code FMK
  • Causa
    Lancets were not sterilized within the dose range established by sterilization validation.
  • Acción
    The firm, KooJoo, sent a "MEDICAL DEVICE VOLUNTARY T RECALL" letter dated July 3, 2013 via first class mail to its customer. The letter described the product, problem and actions to be taken. The customer was instructed to identify and hold all safety lancets you have in inventory that was received before June 2013; notify your retail customers of this product recall and complete and return the attached Customer Reply Form via email to heegonkim@hotmail.com and also return form along with any unused/undistributed product for replacement. If you have further questions, please email heegonkim@hotmail.com or call 209-403-9191 during 9:00am to 5:00pm M-F PST.

Device

Device Recall Odyssey
  • Modelo / Serial
    Lot # HBM1303-4886, Exp 3/6/2016; Lot# HBM1303-4886, Exp 3.6 to 3/21/2016; Lot# HBM1201-02, Exp 1/16/2015; Lot# HBM1203-02, Exp 4/5/2015
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution GA only.
  • Descripción del producto
    Safety Lancets - Odyssey, Button Activated; || Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. || 26G - Single Use Only, || Made In Korea || Distributed by Hummingbird Medical, Savannah, GA || 100 count Boxes; 40 boxes per case || Blood collection by penetrating skin with needle.
  • Manufacturer
    KooJoo Trading Company

Manufacturer

KooJoo Trading Company
  • Dirección del fabricante
    KooJoo Trading Company, 116-7 Songma-li, Daegoj-myun, Gimpo City, Gyeongki-Do Korea, Republic Of (South)
  • Empresa matriz del fabricante (2017)
    Koojoo Trading Co.
  • Source
    USFDA