Events

Retiro De Equipo (Recall) de Sterilized gowns and towels. || LINEN PACK II - contains 12 towels, 1 each large gortex scrub nurse gown/towel, 1 each extra large surgeons gown/towel, 2 36'' re-usable wrappers, 1 24'' re-usable wrappers || Surgical gown packs, inside double wrappers, for use in surgery and operating rooms. Packs include gowns and towels. || Packages are labeled ''STERILE SURGICAL SYSTEMS, LLC ** Tumwater, Washington ** Catalog # ** Quantity ** MFG Date ** Order No. ** Contents ** Contents of the unopened, undamaged package are sterile. Do not resterilize***

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 Sterile Surgical Systems Llc.

¿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
    25118
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0440-03
  • Fecha de inicio del evento
    2002-06-04
  • Fecha de publicación del evento
    2003-01-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-01-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25265
  • 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
    Gown, Surgical - Product Code FYA
  • Causa
    An indicator inside the package did not change to indicate gowns were sterilized.
  • Acción
    The firm telephoned it's two customers on 6/4/02 and offered to have product returned or provide documentation that the sterlizing indicators were defective, and theoretically the gown packs were sterilized.

Device

Sterilized gowns and towels. || LINEN PACK II - contains 12 towels, 1 each large gortex scrub nur...
  • Modelo / Serial
    MFG Dates: 5/24/02, 5/28/02, 5/29/02, 5/30/02, 5/31/02, 6/3/02
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The firm distributed to two hospitals located in the greater Seattle, WA area.
  • Descripción del producto
    Sterilized gowns and towels. || LINEN PACK II - contains 12 towels, 1 each large gortex scrub nurse gown/towel, 1 each extra large surgeons gown/towel, 2 36'' re-usable wrappers, 1 24'' re-usable wrappers || Surgical gown packs, inside double wrappers, for use in surgery and operating rooms. Packs include gowns and towels. || Packages are labeled ''STERILE SURGICAL SYSTEMS, LLC ** Tumwater, Washington ** Catalog # ** Quantity ** MFG Date ** Order No. ** Contents ** Contents of the unopened, undamaged package are sterile. Do not resterilize***
  • Manufacturer
    Sterile Surgical Systems Llc

Manufacturer

Sterile Surgical Systems Llc
  • Dirección del fabricante
    Sterile Surgical Systems Llc, 2757 29TH AVENUE S.W., Tumwater WA 98512
  • Source
    USFDA