Events

Retiro De Equipo (Recall) de Becton Dickinson and Company (BD)

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 Cardinal Health 200, LLC.

¿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
    75297
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0069-2017
  • 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=149995
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    Potential risk associated with corrosion demonstrated on the distraction screw surface.
  • Acción
    On September 23, 2016, Becton Dickinson sent a Field Safety Notice to all affected customers describing the details of the recall and necessary action to take. ACTIONS TO BE TAKEN BY BD: A credit will be applied to your account for the affected product upon receipt of the affected unit(s) or receipt of certification of destruction documented on the customer response form. Complete the Recall Response form certifying that all affected product in your inventory has been destroyed and mail/email a copy of the response form.: The firm requests customers to promptly return the enclosed response form to expedite the correction process and acknowledge receipt of this notification. Or email: GMB-GLB¿VMFieldActions@carefusion.com For further questions, please call (847) 473-1500.

Device

Becton Dickinson and Company (BD)
  • Modelo / Serial
    12 MM Screw Distraction with Product Code: S-0088 and etched with Manufacturing lot number and date:   G11 07/25/2011, J11 10/27/2011, D12 04/24/2012, D12 04/24/2012, F12 06/06/2012, K12 11/06/2012, K12 11/06/2012, L12 12/12/2012, F13 06/20/2013, H13 08/26/2013, I13 09/04/2013, J13 10/29/2013, J13 10/29/2013, A14 01/03/2014, A14 01/22/2014, C14 03/06/2014, D14 04/24/2014, G14 07/31/2014, I14 09/03/2014, L14 12/16/2014, D15 04/01/2015, D15 04/01/2015, F15 06/04/2015, H15 08/11 /2015, I15 09/23/2015, K15 11/18/2015, A16 01/06/2016, B16 02/15/2016, C16 03/08/2016, D16 04/21/2016, E16 05/18/2016 and F16 06/14/2016.   Contained in sterile packages with the following packaging lot numbers and date:  979662 01/07/2011, 985463 03/08/2011, 009375 06/23/2011, 043419 10/21/2011, 064776 02/03/2012, 102167 09/11/2012, 110798 09/25/2012, 127811 12/11/2012, 859648 01/09/2014, 859649 01/09/2014, 859650 01/09/2014, 859651 01/09/2014, 862414 04/23/2014, 862415 04/23/2014, 862416 04/23/2014, 862417 04/23/2014, 862418 04/23/2014, 862419 04/23/2014, 862420 04/23/2014, 868984 02/16/2015, 868985 02/16/2015, 868986 02/16/2015, 873620 08/11/2015, 873621 08/11/2015, 873622 08/11/2015, 873623 08/11/2015, 876504 12/14/2015, 876505 12/14/2015, 876506 12/14/2015, 879271 04/04/2016, 879272 04/04/2016, 881178 06/10/2016, 881179 06/10/2016 and 881180 06/10/2016.   14MM Screw Distraction with Product Code: S-0089 and etched with Manufacturing lot number and date:   E11 05/25/2011, G11 07/28/2011, J11 10/27/2011, C12 03/27/2012, F12 06/12/2012, G12 07/26/2012, I12 09/19/2012, I12 09/19/2012, J12 10/09/2012, J12 10/31/2012, L12 12/03/2012, L12 12/07/2012, A13 01/08/2013, G13 07/19/2013, I13 09/04/2013, J13 10/29/2013, J13 10/29/2013, A14 01/03/2014, A14 01 /22/2014, 014 04/24/2014 I, F14 06/16/2014, F14 06/16/2014, C14 03/06/2014, G14 07/24/2014, I14 09/03/2014, J14 10/17/2014, L14 12/1 6/2014, D15 04/01/2015, D15 04/01/2015, F15 06/04/2015, F15 06/02/2015, G15 07/16/2015, I15 09/15/2015, K15 11/18/2015, A16 01/06/2016, 816 02/15/2016, B16 02/15/2016, C16 03/08/2016 and D16 04/21/2016.  Contained in sterile packages with the following packaging lot numbers and date:  009413 06/22/2011, 038155 10/11/2011, 064187 02/03/2012, 098560 07/12/2012, 100104 07/24/2012, 127814 12/11/2012, 859626 01/09/2014, 859627 01/09/2014, 859645 01/09/2014, 859646 01/09/2014, 859647 01/09/2014, 862172 04/23/2014, 862173 04/23/2014, 862174 04/23/2014, 862194 04/23/2014, 862195 04/23/2014, 862196 04/23/2014, 862197 04/23/2014, 862198 04/23/2014, 862199 04/23/2014, 865271 09/23/2014, 865300 09/23/2014, 865301 09/23/2014, 865302 09/23/2014, 865303 09/23/2014, 865351 09/23/2014, 868947 02/16/2015, 868948 02/16/2015, 868949 02/16/2015, 868950 02/16/2015, 872970 08/05/2015, 872971 08/05/2015, 872972 08/05/2015, 872973 08/05/2015, 873669 08/11/2015, 873670 08/11/2015, 873671 08/11/2015, 876472 12/14/2015, 876473 12/14/2015, 876474 12/14/2015 I, 879298 04/04/2016, 879299 04/04/2016, 881174 06/10/2016, 881175 06/10/2016, 881176 06/10/2016, 881177 06/10/2016 and 985679 03/08/2011.  16 MM Screw Distraction with Product Code: S-0090 and etched with Manufacturing lot number and date:   Al2 1/20/2012, C12 3/27/2012, A13 1/10/2013, J13 10/3/2013 and G14 7/24/2014.  Contained in sterile packages with the following packaging lot numbers and date:  003923 05/12/2011, 098394 07/13/2012, 854634 04/1 9/2013, 854635 04/1 9/2013, 854636 04/19/2013 and 862500 04/23/2013.   18 MM Screw Distraction with Product Code: S-009 and etched with Manufacturing lot number and date:   A12 1/16/2012 and F12 6/12/2012.   Contained in sterile packages with the following packaging lot numbers and date:  120328 10/9/2012, 133021 12/20/2012 and 133021 12/20/2012.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Germany, New Zealand, Saudi Arabia, South Africa, Switzerland and Thailand.
  • Descripción del producto
    V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
  • Manufacturer
    Cardinal Health 200, LLC

Manufacturer

Cardinal Health 200, LLC
  • Dirección del fabricante
    Cardinal Health 200, LLC, 1500 S Waukegan Rd, Waukegan IL 60085-6728
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    USFDA