Events

Retiro De Equipo (Recall) de Device Recall Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm c 40cm)

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 Progressive Medical 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
    63445
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0276-2013
  • Fecha de inicio del evento
    2011-12-09
  • Fecha de publicación del evento
    2012-11-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113796
  • 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
    Dissector surgical General & Plastic Surgery - Product Code GDI
  • Causa
    Some of the sterile packages had broken seals.
  • Acción
    Progressive Medical Inc contacted their customers via telephone on December 9, 2011, through December 15, 2011. Customers were informed the reason for recall was explained and the customer was asked if any of the lot remained in their inventory. If inventory remained, the recalling firm sent them a return goods authorization number and informed them the product would be replaced. For further questions please call (314) 961-5786.

Device

Device Recall Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm c 40cm)
  • Modelo / Serial
    Lot 1108-01
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA (nationwide) including the states of CO, IN, KS, MA, MN, MO, NE, OH, SC, TN, TX, VA, and WI.
  • Descripción del producto
    Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. || The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
  • Manufacturer
    Progressive Medical Inc

Manufacturer

Progressive Medical Inc
  • Dirección del fabricante
    Progressive Medical Inc, 11085 Gravois Industrial Ct, Saint Louis MO 63128-2012
  • Empresa matriz del fabricante (2017)
    Progressive Medical Inc
  • Source
    USFDA