Events

Retiro De Equipo (Recall) de Stic Kit Needle Containment Device

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 EM Innovations 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
    36165
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0056-2007
  • Fecha de inicio del evento
    2006-04-03
  • Fecha de publicación del evento
    2006-10-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-02-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48108
  • 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
    Stic Kit Needle Containment Device - Product Code MMK
  • Causa
    The firm failed to include user instructions with the stic kit needle containment device, model emi 82691, which they shipped to distributor/customers.
  • Acción
    The recalling firm contacted all fifteen (15) of its distributor/customers (not just the distributors that received the affected devices) via telephone on 4/3-5/2006 in order to inform them that the User Instructions had not been included with the needle containment devices that were shipped between 7/5/2005 and 4/3/2006. The firm asked that the distributors check their inventories and if it was determined that User Instructions were missing, report the amount needed to the recalling firm which would in turn send them out. The firm followed up on their recall action via telephone on 7/11/2006, at which time, it was determined that that all of the distributors either had old User Instructions in stock for distribution, or that there were no affected device units left in inventory.

Device

Stic Kit Needle Containment Device
  • Modelo / Serial
    The recalled units are identified with the Lot Codes: 070505 and 110602.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The recalled device was shipped to distributor/customers located in the following states: MO, OH, WI, PA and NJ.
  • Descripción del producto
    Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band.
  • Manufacturer
    EM Innovations Inc

Manufacturer

EM Innovations Inc
  • Dirección del fabricante
    EM Innovations Inc, 6106 Bausch Rd, Galloway OH 43119-9382
  • Source
    USFDA