Events

Retiro De Equipo (Recall) de Device Recall ABGHM1 Hummi Micro Draw Blood Transfer 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 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
    72350
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1636-2016
  • Fecha de inicio del evento
    2015-10-01
  • Fecha de publicación del evento
    2016-05-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140711
  • 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 abg-hm-1 hummi micro draw blood transfer because the connection between the "hummi" y connector and the yellow cannula hub may not be sufficiently secure enough and could separate while in use.
  • Acción
    On 10/01/15 the firm sent out customer notification letters. The letter states for the following actions to be taken: 1. Customers using the Hummi Micro Draw device are recommended not to use the identified lot. 2. A local distributor/sales representative will be contacting customers to arrange a return of the identified lot for credit and arrangement of replacement. 3. Replacement product should be available within 10 days of 10/30/15. 4. During the period of product unavailability customers might want to choose to temporarily to return their previous method for blood drawing. The firm requests a Reply Form be completed and returned via fax at 949-583-2775 or email to JorgeHaider@hummingbirdmed.com. On 11/19/2015 the firm sent out a second notification letter involving additional recall lots. The firm provided the same instructions to customers as their previous notification; however stated replacement product should be available by mid December 2015.

Device

Device Recall ABGHM1 Hummi Micro Draw Blood Transfer Device
  • Modelo / Serial
    Lot 15180, 15286, 15287, 15300, 15305
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of CA, KY, MD, GA, and IL.
  • Descripción del producto
    ABG-HM-1 Hummi Micro Draw Blood Transfer Device || Product Usage: || It is used for blood transfer and collection from Peripheral Arterial Line Catheters.
  • Manufacturer
    Hummingbird Med

Manufacturer

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