Events

Retiro De Equipo (Recall) de Device Recall leg bag

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 C.R. Bard, 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
    77733
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2872-2017
  • Fecha de inicio del evento
    2017-06-02
  • 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=157782
  • 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
    Collector, urine, (and accessories) for indwelling catheter - Product Code KNX
  • Causa
    Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.
  • Acción
    Bard Medical a Medical Device letter dated June 2, 2017 to affected customers via FedEx. The letter identified the affected product, problem and actions to be taken. The notification requests that consignees examine inventory and identify any product on hand. The firm indicates that product return is not required, but customers are encouraged to call 1-800-526-4455 if product doesn't meet their needs or if they have any questions regarding the recall. If product was further distributed, the firm requests that the provided recall notification be forwarded to the respective organization.

Device

Device Recall leg bag
  • Modelo / Serial
    Product Code 151919; Lot No. NGAS4058
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide in the states of CA, CO, FL, IL, IN, LA, MN, MO, NC, NJ, NY, OH, OK, PA, TX, WY, including PR.
  • Descripción del producto
    BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. || Product Usage: || Vinyl leg bag to be used with male external catheters, Foley catheters, or moth other types of urinary catheters, which are intended for use for bladder management including urine drainage, collection and measurement.
  • Manufacturer
    C.R. Bard, Inc.

Manufacturer

C.R. Bard, Inc.
  • Dirección del fabricante
    C.R. Bard, Inc., 8195 Industrial Blvd NE, Covington GA 30014-1497
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA