Events

Retiro De Equipo (Recall) de Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 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
    62386
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0159-2013
  • Fecha de inicio del evento
    2011-10-28
  • Fecha de publicación del evento
    2012-10-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110395
  • 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
    The tip of the product could come loose or unravel.
  • Acción
    The recalling firm sent a letter dated October 28, 2011 to the customer who reported the problem and calls were initiated 6/26/12 to the remainder of the customers. The reason for recall was explained and the customer were 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 questions call 1-800-969-6331.

Device

Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm)
  • Modelo / Serial
    Lot 1104-01
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of: CO, IL, IN, KS, LA, MA, MN, MO, NE, OH, OK, 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. || Product Usage: || 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