Device Recall FLEXICAIR MC3

Fabricante

  • Dirección del fabricante
    Hill-Rom Manufacturing, Inc., 4349 Corporate Road, Charleston SC 29405
  • Source
    USFDA

2 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    All serial numbers. The prefix "IC" is representative of a Flexicair¿ MC3 and a six digit number without a prefix is representative of a refurbished Flexicair¿ MC3.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Canada
  • Descripción del producto
    Flexicair¿ MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.
  • Manufacturer
  • Modelo / Serial
    All Serial numbers. The devices have a nomenclature for each respective product model where the serial number is IBxxxxxx, where xxxxxx is a six digit number. The prefix IB is representative of a Flexicair II, prefix IC is representative of a Flexicair MC3 and a six digit number without a prefix is representative of a refurbished Flexicair MC 3.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, FL, GA, IL, MI , MS, NJ, NY, OH and PA
  • Descripción del producto
    Flexicair¿ MC3 (Model number: M4000) Low Airloss Therapy Units || For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure.
  • Manufacturer