Events

Retiro De Equipo (Recall) de Device Recall BD SurePathTM Preservative Collection Vials

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 & Co..

¿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
    75886
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0877-2017
  • Fecha de inicio del evento
    2016-02-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151578
  • 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
    Processor, cervical cytology slide, automated - Product Code MKQ
  • Causa
    Bd has confirmed that a portion of bd surepath" collection vials associated with specific production lots may contain caps that are cracked which can lead to leaking of the preservative fluid.
  • Acción
    BD Life Sciences sent the initial recall notification on February 12, 2016. The distributors were provided with a written communication via email and customers were provided with a written communication via UPS. For further questions, please call (410) 316-4000.

Device

Device Recall BD SurePathTM Preservative Collection Vials
  • Modelo / Serial
    SurePath Collection Vial Replacement Cap, cat no. 490505 SurePath GYN Preservative Vial Kit, cat no. 490527 SurePath GYN Preservative Vial Kit with Cervex-Brush, cat no. 491095 SurePath GYN Preservative Vial Kit with Cervex-Brush Combi, cat no. 491096 SurePath GYN Preservative Vial Kit with Brush/Spatula, cat no. 491097
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution including BB(Barbados) and PR (Puerto Rico) and to the states of : AK, AL, AR, CA, CO, CT, FL, GA, HI, IA, 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, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and to the countries of: China, Europe, Hong Kong, India, Korea, Mexico, New Zealand, Panama, Singapore, and Taiwan. 480 US customers and 3 US distributors. Product was also shipped to 10 ex-US regions. 15 US government sites received affected product
  • Descripción del producto
    BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. || SurePath¿ Preservative Fluid is designed for use with the PrepStain¿ System. SurePath¿ Preservative Fluid is an alcohol-based, preservation solution that serves as a transport, preservative and antibacterial medium for gynecologic specimens.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Dirección del fabricante
    Becton Dickinson & Co., 7 Loveton Cir, BD Diagnostic Systems, Sparks MD 21152-9212
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA