Recall of Smiths Medical NORMOFLO

29-09-2021

Fluido® is the safe, non-toxic alternative!

Smiths Medical sent out a Field Safety Notice (worldwide), which has resulted in a recall of the Smiths Medical (NORMOFLO) High Flow and Irrigation Fluid Warmers and Warming Sets in the US, Canada and Saudi Arabia.

The FDA has identified this as a Class I recall, the most serious type of recall. The use of these devices may cause serious injuries or death. Other countries will likely follow.

As you are aware various studies were done on the leaching of aluminium into blood and fluids. The results showed various blood and fluid warmers leaching aluminium into the fluid path of the warmers.

The Fluido® Compact, Fluido® AirGuard and Fluido® Irrigation systems do not leach detectable/toxic levels of aluminium or any other inorganic leachables! Fluido® cassettes are coated with parylene to avoid direct contact between the aluminium plates in the cassettes and blood products or IV fluids.

Designed to provide increased safety and ease of use, the Fluido® system helps your patient to remain normothermic without the need to worry about having patients exposed to toxic aluminium levels or other inorganic material. This is substantiated with independent laboratory tests following the ISO 10993 standard series.

Click here for more information and clinical evidence.

 

Strong features and unique selling points

Fluido® AirGuard System and Fluido® Irrigation have strong features and unique selling points compared to other blood and fluid warmers.

Fluido® AirGuard System

  • No detectable aluminium leaching: safe to use
  • Infrared technology: fast warming, temperature at the end of the line
  • Dry technology: no contamination risk
  • Temperature adjustment 30-39°C: flexibility
  • 3 different sets: suitable set for all flows 20-750 ml/min

Download brochure Fluido® AirGuard System

 

         

Fluido® Irrigation

  • No detectable aluminium leaching: safe to use
  • Infrared technology: fast and unlimited warming, temperature at the scope
  • Dry technology: no contamination risk
  • Temperature adjustment 30-39°C: flexibility depending on surgical procedure
  • URO set, patient lines and spike sets: complete range for all patients
  • Special adapters: connection to a pump

Download brochure Fluido® Irrigation