Events

Retiro De Equipo (Recall) de Device Recall SPS1, Static Preservation Solution (UW Solution)

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 Organ Recovery Systems, Inc..

¿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
    75978
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1111-2017
  • Fecha de inicio del evento
    2016-12-14
  • 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=151877
  • 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
    Set, perfusion, kidney, disposable - Product Code KDL
  • Causa
    Organ preservation fluid recalled due to potential for bacterial contamination.
  • Acción
    Firm initiated a voluntary removal of Lot PBR-0060-392 on December 14, 2016. and Lot PBR-0074-330 December 16, 2016. Notification occurred via e-mail to each recipient of the lots. On December 18, 2016, the firm provided subsequent posting notice and FAQs on company website. Follow up telephone conversations were performed post e-mail notifications. Firm worked with FDA to develop and coordinate a unified message that would be noticed on the websites of FDA, UNOS, and CDC. Firm also independently contacted the Association of Organ Procurement Organizations and UNOS to assist with messaging for their constituents. In the recall notification emails, customers were instructed to return affected product to Organ Recovery Systems. All affected product will be destroyed after completion of the firm's internal investigation. Upon learning of the additional lots of potentially contaminated product (PBR-¿0074-¿337 and PBR-¿0060-¿386), on 1/13/2017 ORS notified their customers via email and phone and updated the posting on their website. The instructions were only to quarantine the product, however. On January 23, 2017, firm began instructing their customers (via email) to return the additional affected lots to ORS. An update to their website was posted January 24, 2017. instructing affected customers to return the lots of product. For further questions regarding this recall, please call (847) 824-2421.

Device

Device Recall SPS1, Static Preservation Solution (UW Solution)
  • Modelo / Serial
    Batch / Lot Number: PBR-0060-392, Reference Number: SPS1_1 LITER, Manufacturer Date: 06/22/2016, Expiration Date: 06/22/2018 ;   Batch / Lot Number: PBR-0074-330, Reference Number: SPS1_2 LITER, Manufacturer Date: 07/13/2016, Expiration Date: 07/13/2018  Batch / Lot Number: PBR-0074-337  Batch / Lot Number: PBR-0060-386
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
  • Manufacturer
    Organ Recovery Systems, Inc.

Manufacturer

Organ Recovery Systems, Inc.
  • Dirección del fabricante
    Organ Recovery Systems, Inc., 1 Pierce Pl Ste 475, Itasca IL 60143-1253
  • Empresa matriz del fabricante (2017)
    Organ Recovery Systems Inc.
  • Source
    USFDA