Retiro De Equipo (Recall) de Device Recall Sterilization Wrap

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 Corporation.

¿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
  • 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
    Wrap, sterilization - Product Code FRG
  • Causa
    On june 15, 2017, steris identified that the purple ink located on the outside label of vis-u-all pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch.
  • Acción
    Steris sent an Urgent Voluntary Recall Notice letter dated July 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately inspect on-hand inventory for recalled product. If you have product in your possession, please quarantine it and contact firm to coordinate shipment of replacement product. If you have questions regarding this matter, please contact STERIS Customer Service at 1-800-548-4873.


  • Modelo / Serial
    Model# 883048 Lot# 161116A
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case || Product Usage: || The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
  • Manufacturer


  • Dirección del fabricante
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Empresa matriz del fabricante (2017)
  • Source