Events

Retiro De Equipo (Recall) de 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 Becton Dickinson & Company.

¿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
    75150
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0394-2017
  • Fecha de inicio del evento
    2016-08-02
  • 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=149465
  • 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
    Anesthesia conduction kit - Product Code CAZ
  • Causa
    A recall was initiated by hospira, inc. for several lots of 5% lidocaine hci and 7.5% dextrose injection, usp, 2ml ampul, ndc # 0409-4712-01. some bd" spinal trays contain the 5% lidocaine hydrochloride and 7.5% dextrose injection, usp, 2ml ampul (ndc number 0409-4712-01) being recalled by hospira. as a result, bd is initiating a recall for the affected bd spinal trays.
  • Acción
    BD sent recall letters/business reply card was sent via UPS/email on 8/2/2016. Stericycle is handling returns.

Device

BD
  • Modelo / Serial
    25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B03H034D 1-May-2015 B04J262D 1-Oct-2016   25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B01H034D 1-May-2015 B01H238D 1-Jan-2016 B01H259D 1-Jan-2016 B02J229D 1-Oct-2016 B03J364D 1-Oct-2016 B03K006D 1-Oct-2016 B03K048D 1-Oct-2016 B04H136D 1-Sep-2015  BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B01H035D 1-May-2015 B01H036D 1-May-2015 B01H070D 1-Jun-2015 B01H091D 1-Jun-2015 B01H138D 1-Sep-2015 B02H031D 1-May-2015 B04H119D 1-Jun-2015  BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B01H191D 1-Oct-2016 B02H135D 1-Oct-2016 B03H050D 1-Jul-2016 B03H114D 1-Oct-2016   27G x 3.5 in. BD" Whitacre Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B02H034D 1-May-2015   25G x 3.5 in. BD" Whitacre Spinal Needle, TW Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) B03H153D 1-Sep-2015   27G x 3.5 in. BD" Quincke Spinal Needle 25G x 3.5 in. BD" Whitacre Spinal Needle, TW B02H077D 1-Jun-2015 B03H106D 1-Jun-2015
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    catalog # 405612 || BD Spinal Anesthesia Tray || 22G x 3.5 in. BD" Quincke Spinal Needle || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog # 405622 || BD Spinal Anesthesia Tray || 25G x 3.5 in. BD" Quincke Spinal Needle || Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog # 405623 || BD Spinal Anesthesia Tray || 25G x 3.5 in. BD" Quincke Spinal Needle || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog #405624 || BD Spinal Anesthesia Tray || 25G x 3.5 in. BD" Quincke Spinal Needle || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog # 405634 || BD Spinal Anesthesia Tray || 26G x 3.5 in. BD" Quincke Spinal Needle || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog # 405636 || BD Spinal Anesthesia Tray || 26G x 3.5 in. BD" Quincke Spinal Needle || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog #405641 || BD Spinal Anesthesia Tray || 24G x 3.5 in. Sprotte¿ Needle || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog #405648 || BD Spinal Anesthesia Tray || 22G x 3.5 in. BD" Whitacre Spinal Needle || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog# 405649 || BD Spinal Anesthesia Tray || 22G x 3.5 in. BD" Whitacre Spinal Needle || 25G x 3.5 in. BD" Quincke Spinal Needle || Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog # 405682 || BD Spinal Anesthesia Tray || 25G x 3.5 in. BD" Whitacre Spinal Needle, TW || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog #405684 || BD Spinal Anesthesia Tray || 25G x 3.5 in. BD" Whitacre Spinal Needle, TW || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog #405685 || BD Spinal Anesthesia Tray || 25G x 3.5 in. BD" Whitacre Spinal Needle, TW || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog#405694 || BD Spinal Anesthesia Tray || 25G x 3.5 in. BD" Quincke Spinal Needle || 25G x 3.5 in. BD" Whitacre Spinal Needle, TW || Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog #405704 || BD Spinal Anesthesia Tray || 27G x 3.5 in. BD" Whitacre Spinal Needle || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog #405737 || BD Spinal Anesthesia Tray || 25G x 3.5 in. BD" Whitacre Spinal Needle, TW || Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) || catalog# 405829 || BD Spinal Anesthesia Tray || 27G x 3.5 in. BD" Quincke Spinal Needle || 25G x 3.5 in. BD" Whitacre Spinal Needle, TW
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Dirección del fabricante
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA