Retiro De Equipo (Recall) de Device Recall Hummi

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 Hummingbird Med.

¿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
    73461
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1908-2016
  • Fecha de inicio del evento
    2015-03-11
  • Fecha de publicación del evento
    2016-07-05
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2017-02-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    System, blood collection, vacuum-assisted, manual - Product Code KST
  • Causa
    Hummingbird med devices, inc. is recalling the hummi micro draw because of insertion difficulties.
  • Acción
    The firm, Hummingbird Med Devices, Inc., sent a "Safety Alert" on March 3, 2015 and Addendum on March 11, 2015, to all affected customers. The notification sent on March 3, 2015, instructed customers that: 1) the Hummi Micro device is not recommended to be used with the Baxter Interlink device with the Hummi Micro draw blood transfer device as the Interlink T Connector septum may be damaged. 2) the use of Nexus Medical Micro-T Split Septum T Connector NMT8046 with all uses of the Hummi Micro Draw Blood Transfer device. The connector has been tested and validated for use in combination with the Ameritus Medical's Hummi Micro-Draw Blood Transfer Device. 3) Distributors of the Hummi Micro Draw Device contact and inform all Hummi Micro-Draw Blood Transfer Device users to recommend change to the Nexus Split Septum Micro-T Connector NMT8046 for all uses with the Hummi Micro Draw device. Inservice materials and training on proper Hummi Micro Draw device blunt cannula insertion into the connector's septum will be provided. 4) Distributors complete the attached form indicating hospitals and date contacted, name, and contact information of responsible person and resulting outcome. and 5) Scan and email the attached form to: jorgehaider@humigbirdmed.com or fax to: 1-949-583-2775. On March 11, 2015, the firm sent out a second email to their distributor to inform customers again that only the split septum T-Connector recommended for use with the Hummi Micro Draw is the Nexus Micro T split septum T-Connector. The Nexus Micro T-Connector is designed to provide improved insertion force and eliminate potential leaking while providing a microbial barrier when used with the Hummi Micro Draw device. The Hummi Micro device manufactured in 2015 now has improved lubrication on the blunt tube which makes insertion into smaller septum opening of the Mexud Micro T-Connector smooth and easier to accomplish. The firm states in the letter that the distributor will offer

Device

  • Modelo / Serial
    Lot Numbers: 20140510 20140513 20140516 20140519 20140603 20140606 20140609 20140612 14299
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution in the state of CA.
  • Descripción del producto
    ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Hummingbird Med, 20371 Lake Forest Dr Ste A6, Lake Forest CA 92630-8106
  • Source
    USFDA