Events

Retiro De Equipo (Recall) de Device Recall Welcon

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
    Recall
  • ID del evento
    58021
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2258-2011
  • Fecha de inicio del evento
    2011-01-20
  • Fecha de publicación del evento
    2011-05-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98206
  • 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
    Tray, catheterization, sterile urethral, with or without catheter - Product Code FCM
  • Causa
    The irrigation procedure trays contain triad group alcohol prep pads recalled by triad group because they have the potential to be contaminated with an objectionable organism.
  • Acción
    The firm, Nurse Assist Incorporated, sent a letter dated January 20, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory immediately; quarantine the product; identify their customers and notify them at once about the product recall (Nurse Assist will provide bright labels to affix to your affected inventory); provide their customers with labels as well, and complete and return the attached RECALL ACKNOWLEGEMENT form via fax to: 817-231-1500 or mail to: Nurse Assist, Inc., 3400 Northern Cross Blvd., Forth Worth, TX 76137. Only the product and lots identified on the attached list are affected. If you have any questions or to request labels, please call Nurse Assist Customer Service Monday through Friday, from 8:00 am to 5:00 pm Central Time at 1-800-649-6800.

Device

Device Recall Welcon
  • Modelo / Serial
    Lot Code:902031, 903109, 906382, 909103, 1001118, 1002217, and 1005019
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • Descripción del producto
    Case Label: REORDER NO. 6122 STERILE WELCON BRAND 60cc PISTON SYRINGE With Sterile Saline 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com || Tray Label: REORDER NO. 6122 STERILE UNLESS OPENED OR DAMAGED nurse assist incorporated A6012, R1 WELCON BRAND SINGLE USE Thumb Control Ring Piston Syringe With 100 mL Sterile Saline 0.9% 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: 1200 mL Graduated Drain Tray 100 mL Sterile Saline 0.9% Thumb Control Ring Syringe Protective Cap Prep Pad Waterproof Underpad || Intended use: The trays are irrigation trays for catheters
  • Manufacturer
    Nurse Assist, Inc

Manufacturer

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