Events

Retiro De Equipo (Recall) de Replacement Gastrostomy Device

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
    49523
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0418-2009
  • Fecha de inicio del evento
    2008-09-23
  • Fecha de publicación del evento
    2008-12-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73867
  • 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
    Gastrointestinal Tube (and accessories) - Product Code KNT
  • Causa
    Gastrostomy device anti-reflux valve may allow leakage from the stomach.
  • Acción
    Customers notified by letter (Product Field Action letter) on September 23, 2008 and instructed to remove and return any affected product to Bard Access Systems, Inc (BAS). Customers were instructed in the recall letter to respond by completing and faxing the enclosed Reply Form and Inventory Reconciliation Form. For assistance, contact BAS customer service at 800-290-1689.

Device

Replacement Gastrostomy Device
  • Modelo / Serial
    43AOA020,  43AOA012,  43APA014,  43JQA028,  43APA034,  43KNA054,  43KPA015,  43ARA030,  43KQA028,  43BOA017,  43LNA024,  43BPA010,  43LNA054,  43BQA007,  43LOA009,  43BQA044,  43LOA025,  43COA015,  43LPA112,  43CPA014,  43LQA003,  43CQA015,  43LQA030,  43CQA234, HURA1274,  HURB2527,  43DOA012,  HURB4359,  43DPA016,  HURB4563,  43DPA045,  HURD1919, 43DPA206,  HURE2891,  43DQA009,  HURF0487,  43EOA015,  HURG1446,  43EOA043,  HURH1082,  43EPAO15,  HURJ0005,  43EPA042,  43EPA217,  HURJ0597,  43EQA010,  HURCA095,  43FOA078,  HURE2892,  43FOA109,  HURF0486,  43FOA229,  HURG1447,  43FQA001,  HURH1081,  43GOA011,  HURJ0598,  43GPA147,  HURJ1559,  43GPA148,  43GPA196R,  43GPA230R,  43GPA231R,  43GQA002,  43GQA033,  43HOA033,  43HPA020,  43HPA051, 43HQA002,  43HQA155,  43HQA163,  43IOA013,  43IOA040,  43IPA019,  43IPA212,  43IPA213,  43IQA003,  43JNA003,  43JOA016,  43JPA015,  43JPA193, and  43JQA002.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including US, Latin America and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, Great Britain, Italy, France, Switzerland, Spain, Germany.
  • Descripción del producto
    Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00202W, 16F, 2.4cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. || Dual Port Wizard Low Profile Replacement Gastrostomy Device is a silicone low-profile balloon-type device designed for percutaneous insertion through an established, appropriately sized stoma tract. || The Dual Port Wizard Device is packaged in a kit which also includes two tubes, two gauze pads, and a syringe. The Wizard anti-reflux valve is a component of the Dual Port Wizard Gastrostomy Device. The inserted device is used for enteral feeding.
  • Manufacturer
    C R Bard Inc

Manufacturer

C R Bard Inc
  • Dirección del fabricante
    C R Bard Inc, 605 N 5600 W, Salt Lake City UT 84116-3738
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA