Events

Retiro De Equipo (Recall) de JS Series SterilContainer S2

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 Aesculap Implant 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
    79089
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0624-2018
  • Fecha de inicio del evento
    2017-09-08
  • Fecha de publicación del evento
    2018-02-15
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161320
  • 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
    Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
  • Causa
    The js series sterilcontainer s2 system was released to the market place prior to an authorized fda 510k clearance. no other aesculap sterilcontainer system products are impacted by this recall.
  • Acción
    On August 24, 2017 a Medical Device Recall(Reference 2916714-08/24/2017-010R) was issued requesting that all customers take the following steps: 1.Review the Urgent Medical Device Recall Notification Letter in its entirety and ensure that all users in your organization and other concerned persons are informed about this recall and immediately discontinue use. 2. Determine your current inventory of affected containers within your facility. Immediately quarantine the affected products. A sales representative will come to your facility and remove your affected product and immediately return it to Aesculap Inc. They will assist you with ordering an appropriate replacement container. Do not destroy any affected products. 3. Please contact Customer Service and they will provide you a Returned Good number and a return label. Customer Service: Phone: 1-800-282-9000 aesculap_emailorders.bbmus_service@bbraun.com

Device

JS Series SterilContainer S2
  • Modelo / Serial
    JS440 S2 1/1CONT.BOTTON PERFOR.H88MM H202 JS441 S2 1/1 CONT.BOTTOMPERFOR.H1118MM H202 JS442 S2 1/1-CONT.BOTTOM PERFOR.H133MM H202 JS444 S2 1/1 CONT.BOTTOM PEFOR.H185MM H202 JS489 S2 1/1-CONTAINER LID H202 JS740 S2 3/4 CONT.BOTTOM PERFOR.H88MMH202 JS741 S2 3/4 CONT.BOTTOM PERFOR.H118MM H202 JS742 S2 3/4 CONT.BOTTOM PERFOR.H133MM H202 JS789 S2 3/4 CONTAINER LID H202 JS340 S2 1/2 CONT.BOTTOM PERFOR.H88MM H202 JS341 S2 1/2 CONT.BOTTOM PERFOR.H118MM H202 JS342 S2 1/2 CONT.BOTTOM PERFOR.H133MM H202 JS389 S2 1/2 CONTAINER LID H202
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationally
  • Descripción del producto
    JS Series SterilContainer S2 System
  • Manufacturer
    Aesculap Implant Systems LLC

Manufacturer

Aesculap Implant Systems LLC
  • Dirección del fabricante
    Aesculap Implant Systems LLC, 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Empresa matriz del fabricante (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA