Events

Retiro De Equipo (Recall) de Device Recall Sarns SoftFlow Extended Aortic Cannulae

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
    68404
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2099-2014
  • Fecha de inicio del evento
    2014-05-23
  • Fecha de publicación del evento
    2014-07-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127524
  • 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
    During an in-process inspection, terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded finished product specifications.
  • Acción
    Terumo sent an Urgent Medical Device Recall letters dated June 27, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Review this Medical Device Recall notice, 2. Assure that all users in your institution have received notice of this issue and remove any affected units from use, 3. Fill out the Product Tracking Sheet (enclosed), indicating the number of affected units at your institution and fax to 1-877-907-7509 or email to terumo4967@stericycle.com. 4. Complete the Packing Slip (enclosed) and follow the packing instructions to return the affected product, and 5. Terumo CVS will issue credit once the affected units are returned. For questions call Terumo CVS c/o Stericycle 1-866-629-6181.

Device

Device Recall Sarns SoftFlow Extended Aortic Cannulae
  • Modelo / Serial
    Part No. 4948, Lot #: 0646471, 0652314, 0652909, 0656645, 0658692, 0662071, 0666665, 0669799, 0672089, 0675750, 0676585, 0678728, 0681792, 0684780, 0685667, 0688001, 0691202, 0693823, 0694711, 0696205, 0698300, 0708186, 0708766, 0710058, 0711914, 0714958, 0716134, 0717932, 0719278, 0721688, 694711R, 696201R; Part No. 4949, Lot #: 0646532, 0650731, 0651656, 0652458, 0655167, 0659823, 0661134, 0666626, 0667247, 0668568, 0669798, 0672411, 0675022, 0677305, 0677868, 0678727, 0681772, 0683304, 0683963, 0685668, 0687773, 0688994, 0694411, 0694706, 0695244, 0698301, 0703802, 0708185, 0708765, 0710054, 0711276, 0715262, 0716637, 0718634, 0720571, 695244R, 696204R; Part No. 4949X, Lot #: 0645381, 0653211, 0661604, 0667107, 0669928, 0684001, 0694715, 0712872, 694715R; Part No. 4950, Lot #: 0648462, 0650495, 0656442, 0657280, 0660743, 0674021, 0678721, 0681807, 0684779, 0687498, 0689723, 0693829, 0698851, 0708778, 0710056, 0711836, 0713283, 0719706, 693829R, 695465R; Part No. 4951, Lot #: 0645876, 0649394, 0653430, 0660668, 0661526, 0667894, 0668979, 0674463, 0675778, 0677306, 0678217, 0681808, 0686128, 0687960, 0694412, 0696144, 0696612, 0698299, 0702118, 0708768, 0710037, 0711275, 0713301, 0722066, 696144R & Part No. 4951X, Lot #: 0668569, 0677303, 0696145, 0712873, 696145R.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.
  • Descripción del producto
    Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, || Product Usage: || The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

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