Events

Retiro De Equipo (Recall) de Device Recall KimVent Microcuff subglottic Suctioning Endotracheal Tube

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 Halyard Health.

¿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
    69910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0865-2015
  • Fecha de inicio del evento
    2014-11-17
  • Fecha de publicación del evento
    2014-12-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131943
  • 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
    Tube, tracheal (w/wo connector) - Product Code BTR
  • Causa
    The cuff inflation line may detach from the endotracheal tube during use.
  • Acción
    The firm, Halyard Health, sent an "URGENT: VOLUNTARY PRODUCT RECALL" letter dated November 17, 2014 via FedEx to its Consignees/customers. The letter describes the product, problem and actions to be taken. 'the customers were instructed to please evaluate your facilities for unused inventory of KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes, if present, quarantine and discontinue use; complete the attached Distributor Product Recall Response Form via fax to: 678-254-0391 within five (5) business days of receipt of this letter; if you are in possession of the affected product lots, a Halyard Health representative will provide a return authorization and instructions on shipping product to a specified distribution center, and; follow your internal product recall procedures to identify and address affected product. If you require further assistance, please call Halyard Health Regulatory Affairs at 770-587-7400.

Device

Device Recall KimVent Microcuff subglottic Suctioning Endotracheal Tube
  • Modelo / Serial
    Product Code: 13220, Lot numbers: AA3213, AA3227, AA3227V01, AA3245, AA3245V02, AA3253V02, AA3269V01, AA3274V01, AA4038, AA4038V03, AA4038V04, AA4038V06, AA4062, AA4062V01, AA4104V02, AA4111V01, AA4113V01, AA4134V01 & AA4146V01, AA4146V04, AA4174V01.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) AL, AR, AZ, CA, CT, FL, GA, IN, KS, KY, MA, ME, MI, MO, MS, MT, ND, NH, OH, OK, OR, PA, TN, UT, VA, and WV; and countries of: Australia, Canada, Europe (i.e., France, Germany, Great Britain, Ireland, Italy, Netherlands, Portugal, Sweden, & Switzerland), Hong Kong, New Zealand, and United Arab Emirates.
  • Descripción del producto
    KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
  • Manufacturer
    Halyard Health

Manufacturer

Halyard Health
  • Dirección del fabricante
    Halyard Health, 1400 Holcomb Bridge Rd, Roswell GA 30076-2190
  • Empresa matriz del fabricante (2017)
    Halyard Health Inc
  • Source
    USFDA