Events

Retiro De Equipo (Recall) de Device Recall Reprocessed Ethicon Xcel Trocar Sleeve

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 Sustainability Solutions.

¿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
    71805
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2468-2015
  • Fecha de inicio del evento
    2015-07-10
  • Fecha de publicación del evento
    2015-08-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139129
  • 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
    Laparoscope, general & plastic surgery, reprocessed - Product Code NLM
  • Causa
    Stryker sustainability solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (cb5lt) while the devices inside of the packaging were 75mm models (cb5st).
  • Acción
    On 07/10/15 the firm sent out notification letters to all customers. The letter states for the customer to discontinue use of the affected lot, and to use other trocar lots reporcessed by the firm. The firm requests that the Recall Effectiveness Check Form be completed. The firm is going to be sending a sales representative to the facilities to check inventory for the affected trocars. A Recall Effectiveness Check will also be completed. If the form indicates that affected devices remain in inventory a prepaid shipping label will be issued for the return of the product. Customers will receive credit for all affected devices returned. The form must be completed even if no affected devices are found in inventory. Stryker Sustainability Solutions Complaint Hotline: 1-888-888-3433 x5555

Device

Device Recall Reprocessed Ethicon Xcel Trocar Sleeve
  • Modelo / Serial
    Lot number 3574704 UDI Code: (01)00885825014421(17)180310(10)3574704 Model Number: CB5ST (labeled as CB5LT)
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    U.S. Nationwide Distribution to the following states of:: NV, NM, TX, and MI.
  • Descripción del producto
    Stryker || Sustainability Solutions || CB5LT || Ethicon Endo-Surgery, Inc. || Excel Trocar Sleeve || w/Stability Sleeve || 5mm x 100mm || Reprocessed by Stryker Sustainability Solutions || Product Usage: || The Reprocessed Ethicon ENDOPATH¿ XCEL Universal Trocar Stability Sleeve is a sterile single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Dirección del fabricante
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA