Retiro De Equipo (Recall) de Urethal Insertion Tray 14Fr Red Rubber Catheter with PVP Swabs

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 Nurse Assist, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Catheter, urological - Product Code KOD
  • Causa
    Nurse assist, inc. received a recall notice from the triad group. this recall has been initiated due to a recall of the pvp solution packs manufactured by the triad group that are contained in certain procedure trays.
  • Acción
    Nurse Assist sent a recall notice dated September 2, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately and quarantine the affected product. Customers were also instructed to identify their customers and notify them at once of the product recall. Customers were instructed to complete and return the enclosed response form as soon as possible. For those distributors that choose to destroy the affected product they must use the attached Notice of Destruction to report the specifics of the destroyed product. and contact Nurse Assist Customer Service for a RGA # prior to destruction. For any questions call Nurse Assist Customer Service at 1-800-649-6800.


  • Modelo / Serial
    Assembly ID UT81501400U. Lot Numbers: 906038 (2024211), 907228 (2079813), 908267 (2118324), 908347 (2124088), 909175 (2145038), 909324 (2155647), 910222 (2183854), 910408 (2197503), 912005 (2242896), 1006003 (2455210), 1007027 (2494618), 1007373 (2521822), 1010210 (2619060). Pack Lot #s: 35317, 35317, 35683, 35853, 35995, 36146, 36302, 37026, 37162, 37273, 37673.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Canada and Saudi Arabia.
  • Descripción del producto
    REF UT8150 Urethal Insertion Tray 14Fr Red Rubber Catheter with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Distribue par: Coloplast Canada Corporation 3300 Ridgeway Drive Unit 12 Mississauga, Ontario Canada L5L 5Z9 1-905-820-7588 || Urethal Insertion Tray 14Fr Red Rubber Catheter with PVP Swabs
  • Manufacturer


  • Dirección del fabricante
    Nurse Assist, Inc, 3400 Northern Cross Blvd, Fort Worth TX 76137-3600
  • Empresa matriz del fabricante (2017)
  • Source