Events

Retiro De Equipo (Recall) de 12 Instrument Sterilization Tray

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 Stryker Endoscopy.

¿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
    68045
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1544-2014
  • Fecha de inicio del evento
    2014-04-16
  • Fecha de publicación del evento
    2014-05-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126854
  • 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
    Electrosurgical, cutting & coagulation & - Product Code GEI
  • Causa
    Gravity sterilization parameters provided in the 12 instrument sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.
  • Acción
    Stryker sent an Urgent Device Corrections letters dated April 18, 2014 to all US customers via certified mail. Stryker Sales representative and Stryker international distributors were notified with the letter and response card by e-mail. International sites are responsible for notifying customers. The letter identified the affected product, problem, potential hazards and actions to be taken. Customers were instructed to complete and sign the enclosed Acknowledgement of Receipt form and scan and e-mail to endorecall@stryker.com. For questions call 1-800-624-4422 option 3 or via email at endorecall@stryker.com.

Device

12 Instrument Sterilization Tray
  • Modelo / Serial
    Model number: 0242000012; Lot/serial numbers: 021464-2, 39824-1-1, 4014, 643893-1-4, 27419, 42901-1-1, 35728-2-1,  48639-1-8, 021464-3, 40288-1-1, 43020, 43893-1-6, 27701, 43104-1-1,  36175-1-1, 48956-1-1, 23027, 40629-3-,1, 43622, 43893-1-7, 29129,  43270-1-1, 36421-1-1, 48956-1-1A, 23398, 40721-1-1, 50476,  43893-1-8, 29670, 43523-1-1, 36424-1-1, 51304-1-1, 23542,  41231-4-1, 54990, 43893-1-9, 30250, 43523-1-1A, 37251-1-1,  51304-1-1A, 23846, 41478-1-1, 7J1, 48639-1-2, 30919, 43674-1-1,  37392-1-1, 52123-1-1, 24073, 41745-1-1, 123, 48639-1-3, 3218., 43893-1-1, 37794-1-1, 52956-1-1, 24511, 42086-1-1, 28646-1-1,  48639-1-4, 33226, 43893-1-10, 38867-1-1, 54346-1-1, 26445,  42306-1-1, 29005-1-1, 48639-1-5, 33961, 43893-1-1, 1SS15327, 26843,  42526-1-1, 30384-1-1, 48639-1-7, 35933, 43893-1-12, 37991, 36610,  43893-1-13, 39219, 43893-1-2, 43893-1-14.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution
  • Descripción del producto
    12-Instrument Sterilization Tray; || Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held. The tray features silicon device holders that secure devices during the sterilization process.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Dirección del fabricante
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA