Events

Retiro De Equipo (Recall) de Device Recall T5 Hytrel Zipper 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
    Recall
  • ID del evento
    61848
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1809-2012
  • Fecha de inicio del evento
    2012-06-01
  • Fecha de publicación del evento
    2012-06-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109236
  • 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
    The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.
  • Acción
    Stryker sent the May 29,2012 URGENT MEDICAL DEVICE RECALL NOTIFICATION and the June 14, 2012 REVISED URGENT MEDICAL DEVICE RECALL Notice to all consignees. The letters identified the affected products, problem and actions to be taken. The Revised letter instructed customers to find, quarantine, make product unusable and destroy all implicated product . Replacement products may not immediately available. Customers were asked to complete and sign the Business Reply Form (BFR) and fax to Stryker Instruments Regulatory Department at 866-521-2762. If the affected products have been further distributed, forward this notification letter and the attached BRF to all affected locations. Questions should be addressed to Angela Ragainis, 269-389-4354; angela.ragainis@stryker.com

Device

Device Recall T5 Hytrel Zipper Toga
  • Modelo / Serial
    Part 0400-821-100, 0400-841-100 , 0400-851-100 0400-851-100S1, and 0400-851-100S2 all lots
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including the states of: AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the country of SWITZERLAND
  • Descripción del producto
    T5 Hytrel Zipper Toga. || Product Usage: || The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

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