Retiro De Equipo (Recall) de Device Recall McKesson

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
    The trays contain triad group sterile lubricating jelly packs recalled by triad group because of the possibility of inadequate sterilization.
  • 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.


  • Modelo / Serial
    Lot Codes: 804192, 808059, 809086, 810246, 812040, 812198, 902029, 902286, 904074, 905128, 906279, 907368, 908385, 909389, 911130, 912280, 1001222, 1003022, 1003390, 1004260, 1006033, 1007077, 1008230, 1010077, and 1011135.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • Descripción del producto
    Case Label: McKESSON Medi-Pak Ureteral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable 20 Trays Per Case Reorder No. 37-232 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. || Tray Label: McKESSON Medi-Pak Urethral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable Contents: 1-14 FR Red Rubber Catheter, 1-Pair of Vinyl Gloves, 1-Specimen Container with Lid and Label, 1-Fenestrated Drape, 1-Pack of Three PVP Swabsticks, 1-Pack of Lubricating Jelly, 1- Polylined Drape, 1-Graduated Tray, 1200 cc Reorder No. 37-232 Contents STERILE In unopened, undamaged package. Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 || Intended use: The trays are urological catheter trays.
  • Manufacturer


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