Retiro De Equipo (Recall) de Cardiovascular Procedural Kit with Centrifugal Pumphead

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 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
    Recall
  • ID del evento
    68024
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2030-2014
  • Fecha de inicio del evento
    2014-04-14
  • Fecha de publicación del evento
    2014-07-11
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2016-09-07
  • Fuente del evento
    USFDA
  • 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
    Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
  • Causa
    During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
  • Acción
    Urgent Medical Device Recall letters, dated April 11, 2014, were sent to customers. The letters identified the affected product, as well as the reason for the correction, the potential hazard, the correction, the affected population, and instructions for customers. Customers are to review the notice and ensure that all users have received a copy. Additionally, customers are to confirm receipt of the communication by returning the attached Customer Response Form as instructed; and, return all effected centrifugal pumps. Terumo CVS will issue a Returned Goods Authorization upon receipt of the Response Form. Questions should be directed to Terumo CVS Customer Service at 800-521-2818.

Device

  • Modelo / Serial
    Pack Lot Nos. RA27T, RA20, RA06T, QP09A, QN18A, RA06A, QP16A, RA20A, RC03A, and RC17T.   QM21, RA27, RA27R, QN07, QM28, QF13A, QM21, QN25, QP16, QM14, QN18, QN11, QN04, RA13, QF06R, RC10, QM14T, QM21A, RC24, QF06, QP09, QF20A, QF13R, QF06RT, QG03RA, QG17, QL03, QM14T, QN25A, QE29, QE29T, QL16, QM28A, QM28C, QM28T, QK05, QK05AC, QK26, QK26A, QL02, QL16, QL16A, QL23, QN11A, QF20, QH08, QP02A, QP16, RC03, RA02, RA06, RC24, QK26, QE15, QM21T, QP02A, RA27A, QM07, QL02, QH08, QN25, QG17, QF06, QF06T, QF13, QF13T, QF13TA, QN18, QA21R, QE29T, QF28, RC03, QF28, RC17, QF06, RA13, QF20, QL03, RA27A, QH22, QG10, and RC24.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. || Catalog numbers || 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 74031-01, 73312-01, 74362, 74928, 74928-01, 72997-03, 74277, 70334-03, 73230, 73728, 71537, 73605-01, 74482-01, 74857-01, 74916, 73928-02, 70123-02, 71853-02, 72997-03, 74766, 71537, 73728, 72269, 74466, 71317-02 72991-02, 74951, 74336, 74121-01, 72941-01, 73315-03, 74559, 74277, 71382-01, 73108-02, 74178-03, 71598-02, 73108-02, 74618-01, 70334-03, 74802-01, 74916, 71932-02, 70951-03, 73957-01, 74857-01, 70957-02, 73449-01, 73124, 71546-02, 72892-01, 74431, 72370, 73913-01, 73957-01, 75028, 71820-01, 74201, 74402, 73891-01, 73865, 73972, 71175-01, 73208-03, 72669-02, 70533-09, 72275-01, 74369, 74321-01, 73175, B73235, 74459, 73931, 74262-01, 71002-01, 74879-01, 71801-01, 72384, 74365, 74366, 74348-01, 72072-02, 74048, 70932-03, 73407, 74879-01, 73820-01, 74161-01, 72991-02, 73288-01, 70016, 70466-08, 70188-04, 72238-02, 72817-01, 71103-02, 71717-01, 70957-02, 70196-02, 73872-02, 71896-02, 73191-01, 70977-05, 73438, 73201-01, 74671, 70367-07, 73276-02, 74482-01, 73551-02, 71537, 74348-01, 73211-01, 74430, 72026-03, 74502, 74873, 73652-01, 74163-02, 71733-02, 70075-06, 72846, 73820-01, 75063, 74155-01, 74454-01, 73428-01, 73442-01, 70664-01, 70012-05, 70099-03, 70159-05, 70917, 72965-02, 73645-01, 74417, 73346, 74433, 74737, 73055-02, 70227-04, 70880-05, 71934-02, 72073-01, 72149-01, 74120-01, 72370, 73662-03, 74251, 73872-02, 70658-09, 74550, 74124, 74096-01, 74203, 70174-09, 71485-01, 71905-01, 73124, 73874, 74467-01, 8327TXC-08, 8365TXC-01, 8390TXC, 74433, and 74737. || For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Terumo Cardiovascular Systems Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA