Events

Retiro De Equipo (Recall) de Needle, Biopsy

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
    53615
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0274-2010
  • Fecha de inicio del evento
    2009-10-08
  • Fecha de publicación del evento
    2009-11-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86080
  • 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
    kit, needle, biopsy - Product Code FCG
  • Causa
    The recall was initiated after the firm determined that some magnum disposable biopsy core needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a loose hub connection. the exposed sample chamber will typically result in an inability to obtain the biopsy sample. in the majority of reported cases, there was no injury to the patient or user. when us.
  • Acción
    The recall notification was initiated by the firm issuing an urgent medical device notification to it's consignees on October 08, 2009 via USPS requesting them to check all inventory locations for the affected products, remove and return affected products to Bard. The consignees were instructed to complete and return a recall effectiveness check form. Bard provided this 800 number 1-800-321-4254 for any questions consignees may have.

Device

Needle, Biopsy
  • Modelo / Serial
    Lot Number: REQI0632 REQJ0353 REQK0281 REQK0377 RERA0355 RERB0142 RERC0031 RERD0071 RERD0117 RERE0156 RERE0547 RERG0317 RERH0719 RERI0584 RERK0426 RERL0187 RESA0699 RESB0560 RESC0584 RESD0592 RESE0373 RESF0560 RESG0181 RESH0718 RESI0438 RESJ0549 RESJ0550 RETB0903 and RETB0904
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and internationally to Canada Mexico Algeria Andorra Austria Bahrain Belarus Belgium Croatia Cyprus Czech Republic Denmark Finland France French Guiana Germany Gibraltar Greece Hungary Ireland Israel Italy Ivory Coast Kenya Kuwait Latvia Lebanon Luxembourg Malta Martinique Mauritius Morocco Netherlands New Caledonia Nigeria Norway Oman Poland Portugal Republic of Kosovo Republic of Macedonia Reunion Romania Russia Saudi Arabia Senegal Serbia Seychelles Slovenia South Africa Spain Sweden Switzerland Syria Tunisia Turkey Ukraine United Arab Emirates United Kingdom Australia New Zealand Canada Japan Bangladesh China Hong Kong India Indonesia Korea Malaysia Pakistan Singapore Sri Lanka Taiwan Thailand Vietnam Argentina Bahamas Barbados Brazil Chile Colombia Dominican Republic Mexico Peru and Suriname
  • Descripción del producto
    Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1613. || Bard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

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