Retiro De Equipo (Recall) de Custom Tubing Pack with Bioline Coating

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 Datascope 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
  • Estado del evento
    Open, Classified
  • País 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
    Reservoir, blood, cardiopulmonary bypass - Product Code DTN
  • Causa
    The better bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. seal separation from the housing may allow air to enter the housing and collapse the balloon. this may increase resistance to flow in the venous line and cause a drop in ecmo circuit blood flow.
  • Acción
    Affected consignees were notified by letter delivered via FedEx on October 19, 2017. After CTI expanded their recall in March 2018, Getinge accordingly alerted additionally affected consignees by letter delivered via FedEx on April 5, 2018. The recall letter advised customers of the issue and referenced the CTI recall notification, which was included as an attachment to Getinge's communication. End-users were instructed to examine their inventory to determine if they had any of the affected catalog/lot numbers. Any affected product is to be immediately quarantined and returned to Getinge by contacting Customer Service at 1(888) 627-8383 (option 2, then option 2 again), Monday through Friday, 8AM-6PM. In addition, customers were asked to complete a response form to acknowledge receipt of the notification, and return to Getinge. After communications with some end-users who were concerned about maintaining inventory of custom tubing kits, Getinge revised their recall strategy to include an option for replacement of the recalled Better Bladder device. Customers who wished to receive a replacement device will be provided with the device and a notice which must be affixed to the recalled kit. This will ensure that at time of use, it will be obvious to the user that the Better Bladder device inside the kit must be switched out with the replacement device prior to use. The removed recalled Better Bladder device must then be sent back to the recalling firm, Getinge. This information was communicated to customers via telephone call or visit on 4/20/18, and a summary of the communication was sent as an amended recall notification to customers who stated during the phone call that they still had recalled product on 4/21/18. Maquet/Getinge Customer support may be reached at 1(888) 627-8383 (press option 2, then option 2), Monday through Friday, 8AM-6PM.


  • Modelo / Serial
    Lot 3000067221
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.
  • Descripción del producto
    BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
  • Manufacturer


  • Dirección del fabricante
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-3206
  • Empresa matriz del fabricante (2017)
  • Source