Retiro De Equipo (Recall) de Device Recall Hytrel Toga

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 Instruments Div. of Stryker 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
  • 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
    Gown, surgical - Product Code FYA
  • Causa
    Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. the test method used involved high heat to accelerate the aging of the packaging. stryker is conducting additional testing and assessing this pr.
  • Acción
    Stryker sent an Urgent Urgent Recall noitifications letter dated May 7, 2013 via certified US mail and E-mail l to all affected customers, distributors and direct accounts. The letter identified the affected products, problem, risk to health, and actions to be taken. Customers were instructed to check inventory, immediately quarantine any affected product, and open each package before discarding to prevent use. Customers were directed to fill out and return a Business Reply Form to Stericycle, Phone: 888-943-2396 Fax: 888-943-4192, Email: verifying directions and confirming recalled product was destroyed. For questions call 269-389-4354 or 269-389-4518.


  • Modelo / Serial
    1006129, 1103201, 1009197, 1105391, 1009198, 1107548, 1012302, 1109788, and 1102127
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    USA Nationwide Distribution
  • Descripción del producto
    Stryker Instruments 0400-810-000 T4 Zipper Toga || (S/M) Sterile, EO; single use; || Product Usage: || Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
  • Manufacturer


  • Dirección del fabricante
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Empresa matriz del fabricante (2017)
  • Source