Events

Retiro De Equipo (Recall) de Hudson RCI

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 Teleflex Medical.

¿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
    61538
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1427-2012
  • Fecha de inicio del evento
    2012-04-03
  • Fecha de publicación del evento
    2012-04-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108383
  • 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
    Endoscope and/or accessories - Product Code KOG
  • Causa
    Teleflex medical received complaints that the bite block can become separated from the handle. if separation occurs, medical intervention may be required to remove the bite block from the patient's trachea or esophagus/gi tract.
  • Acción
    Consignees received "Urgent Medical Device Recall Notification" letters on or about 04/03/2011. The letters described the issue and provided recommended actions regarding remaining product and returns. Questions were directed to Customer Service at (866) 804-9881 (US).

Device

Hudson RCI
  • Modelo / Serial
    Catalog number: 1140; Lot numbers: 02A0800905, 02C1100483, 02F1000054, 02J0902663, 02A0801994, 02C1101954, 02F1000055, 02J1000939, 02A1000256, 02C1102754, 02F1100700, 02J1001824, 02A1000257, 02D0800059, 02F1101638, 02J1001825, 02A1001314, 02D0801329, 02G0801052, 02K0801935, 02A1001766, 02D0900557, 02G0802642, 02K0803847, 02A1100326, 02D0901732, 02G0900707, 02K0803848, 02A1101331, 02D1100098, 02G0901295, 02K0803849, 02A1102273, 02E0800110, 02G0902610, 02K0900029, 02B0900298, 02E0800342, 02G1000387, 02K0901174, 02B1000808, 02E0802363, 02G1000547, 02K1000019, 02B1000809, 02E0900148, 02G1100211, 02K1000520, 02B1001744, 02E0900638, 02H0800052, 02L1000392, 02B1100389, 02E1000111, 02H0800366, 02L1002223, 02B1101712, 02E1001758, 02H0801439, 02M0900100, 02C0800010, 02E1002588, 02H0801440, 02M0900855, 02C0802808, 02E1100223, 02H0900911, 02M0901463, 02C0901197, 02E1101181, 02J0800358, 02M0902072, 02C1001856, 02F0801932, 02J0801231, 02M1000288, 02C1001857, 02F0900762, 02J0900815 and 02M1000824 and Catalog number: 41140 (sold internationally) Lot numbers: 02A1102347, 02C1000226, 02C1003651, 02C1100970, 02D1001954, 02D1002705, 02D1101766, 02E1000107, 02E1100311, 02G0900700, 02J0802603, 02J1001026, 02K0901769, 02K1000616, 02K1001588, 02L0901972 and 02L1000486.
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Singapore, China, Denmark, Netherlands, India, Australia, Japan and the United Kingdom.
  • Descripción del producto
    Hudson RCI, BiteGard Oral Bite Block, Single Patient Use, Rx Only, Teleflex Medical, Research Triangle Park, NC. The Teleflex Medical BiteGard Molar Bite Black is a disposable single patient use device that fits between the patients molars to prevent the patient from closing their mouth entirely and from obstructing the Laryngeal Mask Airway (LMA) tube, in the case where one is used.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Dirección del fabricante
    Teleflex Medical, 2917 Weck Dr., Research Triangle Park NC 27709
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA