Events

Retiro De Equipo (Recall) de Device Recall Terumo Custom Cardiovascular Kits

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 Terumo Cardiovascular Systems Corp.

¿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
    74856
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2706-2016
  • Fecha de inicio del evento
    2016-07-25
  • 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=148609
  • 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
    Cardiovascular procedure kit - Product Code OEZ
  • Causa
    Terumo custom cardiovascular procedure kits are labeled as xcoating surface coated tubing, but tubing is non-coated.
  • Acción
    Terumo Cardiovascular Systems issued the Safety Alert dated July 25, 2016 and advises the user that their kit may include uncoated tubing, and further advises the consignee to continue using their kits with consideration of anticoagulation protocols during a procedure. Each consignee is asked to complete a Customer Response Form, and to return the Customer Response Form to Terumo acknowledging their receipt of the form. Consignees can return their affected product for credit/replacement; however, return of the product from the field is a customer option and is not under recommendation from Terumo Cardiovascular Systems. For further questions, please call (800) 262-3304.

Device

Device Recall Terumo Custom Cardiovascular Kits
  • Modelo / Serial
    US Lot Codes: UG06  UE18R  UF31  UF31A  UF31T    UG13  UG13A  UG20  UG20T  UG27  UG27T   OUS Lot Codes:  UG13  UG13T  UG20  UG20T
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Foreign: Canada, Latin America
  • Descripción del producto
    Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: || This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a sterile, disposable kit, intended for one-time use for periods up to 6 hours, after which it must be discarded in a manner which is within applicable laws and practices. Terumo Cardiovascular System Cardiovascular Procedure Kits. Each kit is assigned a unique product code/catalog number that is specific to the consignee who has established specifications for the kit. || US Product Codes: || 72021 || 72358 || 71180-01 || 76021 || 76022 || 76023 || 76024 || 76025 || 71801-01 || 71801-01 || 71801-01 || 71801-01 || 71801-01 || 74163-03 || 71296-01 || 74460-01 || 74460-01 || 74460-01 || 73208-03 || 74382-01 || 74382-01 || 74382-01 || 74916 || 74916 || 74916 || 70089-07 || 74063-01 || 74063-01 || 74460-01 || 74460-01 || 74460-01 || 74460-01 || 75252-01 || 74951 || 75881 || 74271-01 || 71085-02 || 72742 || 75314 || 75368 || 75368 || 76095 || 76095 || 73339-01 || 73789 || 74417 || 72204 || 72965-03 || 73644 || 73645-01 || 73700 || 73861 || 73871 || 73901-03 || 75612 || 75617 || 75986 || 76095 || 73645-01 || 73645-01 || 70099-04 || 75544 || 75272 || 75674 || 75674 || 73180 || 73180 || 73180 || 75437 || 75674 || 75274 || 73811 || 73811 || 74915 || 71175-03 || 73738 || 76117 || 75129 || 75642 || 75642 || 72596 || 72596 || 72596 || 75179 || 74980-01 || 8340TXC-07 || 8340TXC-07 || 8340TXC-07 || 71875-01 || 74235-01 || 74476 || 75059 || 75547 || 75547 || 74235-01 || 8351TXC-01 || 73124 || 73281-01 || 73282-01 || 73874 || 74477 || 8340TXC-07 || 76069 || 76070 || 76071 || 76072 || 74737 || 73933 || 73933 || 73933 || 73933 || 73933 || 73933 || 71608-04 || 75413 || 74959 || 75472 || 75472 || 75449 || 75923 || 75923 || 73729-01 || 73730-01 || 74046-
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • Dirección del fabricante
    Terumo Cardiovascular Systems Corp, 28 Howe St, Ashland MA 01721-1305
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    USFDA