Events

Retiro De Equipo (Recall) de Device Recall Sarns flexible arterial cannula

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
    64007
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0668-2013
  • Fecha de inicio del evento
    2013-01-07
  • Fecha de publicación del evento
    2013-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115295
  • 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
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Causa
    Flexible arterial cannula and high-flow aortic arch cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. because the flash has the potential to detach in the operative field, tcvs has decided to remove all affected lots that were manufactured with the affected connector part.
  • Acción
    TERUMO sent an URGENT MEDICAL DEVICE RECALL notification to all consignees on January 7, 2013. Terumo CVS is advising users to discontinue use and return all affected cannulae in inventory. Terumo CVS will issue credit for returned cannulae. Terumo CVS providied a list of marketed devices that can be used as alternatives. Contact Terumo CVS Customer Service with questions or concerns: 800- 521- 2818 Monday  Friday, 8 AM - 6 PM EST For questions regarding this recall call 734-741-6173.

Device

Device Recall Sarns flexible arterial cannula
  • Modelo / Serial
    Lot number: 0677287 and 0681074 and Catalog number: 13030
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain, BRAZIL, CANADA, CHILE, Honduras, Singapore, Taiwan, Trinidad and Tobago, and UNITED ARAB EMIRATES (UAE).
  • Descripción del producto
    Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long || The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Dirección del fabricante
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    USFDA