Events

Retiro De Equipo (Recall) de BARD MAXCORE Disposable Core Biopsy Instrument

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 Bard Peripheral Vascular 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
    70952
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1586-2015
  • Fecha de inicio del evento
    2015-04-09
  • Fecha de publicación del evento
    2015-05-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135737
  • 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
    Instrument, biopsy - Product Code KNW
  • Causa
    The firm is recalling bard max-core disposable core biopsy instrument due to the risk of having self-activation-related issues.
  • Acción
    Bard sent an Urgent Medical Device Recall Notification letter dated April 9, 2015 to their customers. The firm's letter provided customers with the following instructions: -Do not use or further distribute any affected product. -Check all inventory locations within the institution for Bard¿ Max-Core Disposable Core Biopsy Instruments for the recalled product code/lot number combination. -If further distributed any of the product code/lot numbers listed, please immediately contact that location, advise them of the recall and have them return the affected product to BVD address listed. -Remove any identified product from the shelves. -If used the affected product, complete, and return the attached Recall and Effectiveness Check Form indicating no product will be returned. Report any new and/or previously unreported adverse events associated with this recall to the US Food and Drug Administration's ("FDA") MedWatch Program by phone at 1-800-FDA-1088; by fax at 1-800- FDA-0178; by mail to MedWatch. Food and Drug Administration. 5600 Fishers Lane. Rockville. MD 20857- 9787: or on line at http://wwvdda.gov/medwatch/report.htm. Once the product affected by this recall has been removed from inventory: -Fill out the Recall and Effectiveness Check Form. Be sure to state the quantities and lot numbers of each recalled product that are in stock. -Call the firm's Recall Coordinator Regan Gealy at 1-770-784-6471 or email at Regan.Gealy@crbard.com. The Recall Coordinator will issue either a Return Authorization (RCL) Number or Consignment Recall Number (CRC) to facilitate the expedient return of the product. -Fax the Recall and Effectiveness Check Form back to at 1-770-784-6469. -BPV will provide replacement product for the returned product. A mailing label is going to be enclosed to return the affected product. Mark the outside package as "RECALLED PRODUCT" and include the RCL or CRC number. All products should be returned to the follo

Device

BARD MAXCORE Disposable Core Biopsy Instrument
  • Modelo / Serial
    Product Code: MC1820 Gauge x Lengh: 18g x 20cm Lot Numbers: REYA2017, REYC2853
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WI, WV and the countries of: France, Mexico, Netherlands, Panama, United Kingdom, Switzerland, Spain, Poland, Norway, Iceland, Italy, Greece, Finland, Belgium, Germany, Austria, China, Taiwan, Singapore, Korea, Australia, and Japan.
  • Descripción del producto
    BARD MAX-CORE Disposable Core Biopsy Instrument || Gauge x Length || 18g x 20cm || The BARD MAX-CORE Disposable Core Biopsy Instrument is a single patient use core biopsy device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color-coded according to the various gauge sizes e.g., yellow=20 gauge, pink=18 gauge, purple=16 gauge, and green=14 gauge.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc
  • Dirección del fabricante
    Bard Peripheral Vascular Inc, 1625 W 3rd St Ste 109, Tempe AZ 85281-2438
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA