Events

Retiro De Equipo (Recall) de Device Recall Electrode Electrosurgical/Extendable Pencil

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 PSC Industries 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
    62332
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1991-2012
  • Fecha de inicio del evento
    2012-06-05
  • Fecha de publicación del evento
    2012-07-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110239
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    The tyvek pouch label for this device states: 'with holster'; however, this product does not come with a holster. firm officials met with fda on 5/17/2012. at which time, they reported various labeling errors with their button switch pen electrode electrosurgical /extendable pencils.
  • Acción
    Olsen Medical sent an "URGENT:MEDICAL DEVICE RECALL" letter dated June 5, 2012. The letter identifies the product, problem, and actions to be taken by the customers. The letter asks that the customer immediately examine their inventory for the presence of the suspect product and quarantine the product, if found. Customers who may have further distributed the recalled product are asked to contact their (sub-account) customers and notify them of the recall. The customers are also asked to call a toll-free telephone number in order to received a Return Material Authorization (RMA) number and so identify if they would like credit or replacement inventory upon returning the product. The customer is also asked to complete and return the enclosed 'Recall Response Form' and to fax the completed form to the fax number on the form or to send the completed from back to the recalling firm via parcel post.

Device

Device Recall Electrode Electrosurgical/Extendable Pencil
  • Modelo / Serial
    Model Number: 75800, Lot Numbers: 023392 and 022438
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI.
  • Descripción del producto
    Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box. || Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.
  • Manufacturer
    PSC Industries Inc

Manufacturer

PSC Industries Inc
  • Dirección del fabricante
    PSC Industries Inc, 3230 Commerce Center Pl, Louisville KY 40211-1900
  • Empresa matriz del fabricante (2017)
    Pmc Global Inc.
  • Source
    USFDA