Events

Retiro De Equipo (Recall) de Quick Connect

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 Steris Corp.

¿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
    49390
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2462-2008
  • Fecha de inicio del evento
    2008-08-04
  • Fecha de publicación del evento
    2008-09-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73243
  • 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
    Barblocks - Product Code MED
  • Causa
    During ongoing product development testing, it was discovered that, when the two inflow barbs on adapter 201048 # 4 are in a position to face one direction, the top barblock may interfere with the top surface of bottom barb of the adapter. the interference may cause the plunger on the suction side to lift slightly which may affect flow of sterilant into the suction lumen.
  • Acción
    A Steris Field Service Representative will make arrangements to visit each facility to modify the affected Quick Connects. Until that time customers may use the work around instructions for use in the notification letter dated August 4, 2008. Contact Steris Corporation at 1-800-548-4873 or 1-440-392-7455 for assistance.

Device

Quick Connect
  • Modelo / Serial
    QPC1713 Model # QFC1728; Serial #: 3870300, 3870367, 3870326, 3870342, 3923281, 3954195, 4008389, 4045720, 4091419, 4153292, 4201828, 4274429, 4297354, 4247052, C601846, C601879, 4569117, 4710430, 4770715, 4862314, 4899068, 4942173, 5005517, 5098421, and 5261433.  QPC1724 Model # QFC1729; Serial # 3500782, 3531266, 3614856, 3644010, 3681319, 3753928, 3753944, 3754231, 3864709, 3865110, 3879319, 3935418, 3962214, 3967825, 4054979, 4123873, 4186201, C601848, 4274445, 4363339, 4247078, 4479853, 4588679, 4632667, 4684007, 4738753, 4802294, 4810867, 4869749, 4899084, 4942199, 4952487, 4987020, 5026513, 5063789, 5098447, 5159215, 5211669, 5256367, and 5257266
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AK, AL, AR, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, VA, VT, WI, WV and WY. OUS: Canada, Australia, Italy, Spain, and Thailand.
  • Descripción del producto
    Quick Connect component p/n 201048. The component is contained in QPC1713 and QPC1724 Quick Connects. The QPC1724 is used to attach Pentax 70/70K/72/72K/80K/81K/90i/90K SERIES GI ENDOSCOPES WITH WATER JET to the C1160 Universal Flexible Processing Tray in the SYSTEM 1 Sterile Processing System. The QPC1713 is used to attach Pentax 70/70K/80K/85/85K/90K SERIES GI ENDOSCOPES without WATER JET to the C1160 Universal Flexible Processing Tray in the SYSTEM 1 Sterile Processing System.
  • Manufacturer
    Steris Corp

Manufacturer

Steris Corp
  • Dirección del fabricante
    Steris Corp, 5960 Heisley Rd, Mentor OH 44060-1834
  • Source
    USFDA