Events

Retiro De Equipo (Recall) de Device Recall FiberOptix Ultra 8

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 Arrow International, Inc., Division of Teleflex Medical Inc..

¿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
    73266
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1057-2016
  • Fecha de inicio del evento
    2016-02-10
  • 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=143673
  • 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
    System, balloon, intra-aortic and control - Product Code DSP
  • Causa
    The sheath body may become separated from the sheath hub. if the separation occurs, there is a potential for bleeding from the device.
  • Acción
    The firm, Teleflex Arrow International, sent an "Urgent Medical Device Recall Notification" letter dated 2/11/2016 via FedEx to its Customers. The letter described the product, problem and actions to be taken. The customers were informed of the reason for recall and were instructed to take the following actions: 1. If you have any products referenced in the attached enclosure, immediately discontinue use and quarantine those products appropriately. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall FiberOptix Ultra 8
  • Modelo / Serial
    Batch: 18F14A0025 18F14A0026 18F14A0030 18F14A0049 18F14A0050 18F14A0051 18F14A0054 18F14A0057 18F14A0066 18F14A0067 18F14D0045 18F14E0004 18F14E0006 18F14E0016 18F14E0017 18F14E0052 18F14F0017 18F14F0047 18F14F0049 18F14F0080 18F14G0003 18F14G0004 18F14G0021 18F14G0037 18F14G0055 18F14G0056 18F14G0068 18F14G0070 18F14G0071 18F14G0076 18F14H0009 18F14H0030 18F14H0054 18F14H0055 18F14H0060 18F14H0061 18F14J0003 18F14J0005 18F14J0037 18F14K0006 18F14M0001 18F14M0014 18F14M0032 18F15A0005 18F15A0011 18F15A0026 18F15A0034 18F15B0005 18F15B0008 18F15B0010 18F15B0018 18F15B0020 18F15B0027 18F15C0002 18F15C0007 18F15C0010 18F15C0015 18F15C0024 18F15C0030 18F15C0036 18F15D0017 18F15D0032 18F15D0034 18F15D0043 18F15D0049 18F15E0003 18F15E0011 18F15E0014 18F15E0023 18F15E0029 18F15E0037 18F15F0011 18F15F0017 18F15F0021 18F15F0032 18F15G0001 18F15G0013 18F15G0021 18F15G0028 18F15G0034 18F15H0010 18F15H0015 18F15H0021 18F15H0024 18F15H0033 18F15J0013 18F15J0028 18F15J0038 18F15J0044 18F15J0049 18F15K0001 18F15K0007 18F15L0002 18S14G0068 18S14M0001 18S15C0002
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).
  • Descripción del producto
    FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS || The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
  • Manufacturer
    Arrow International, Inc., Division of Teleflex Medical Inc.

Manufacturer

Arrow International, Inc., Division of Teleflex Medical Inc.
  • Dirección del fabricante
    Arrow International, Inc., Division of Teleflex Medical Inc., 9 Plymouth St, Everett MA 02149-1814
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA