Product defect correction: Fluid warming systems may leach aluminium

ANZCA has been made aware that Smiths Medical, the manufacturer of the Level 1 Fast Flow Fluid Warming System and Level 1 Normoflo Irrigation System, has issued a Product Defect Correction. The reason for this notification is to alert users to the potential for aluminium ion leaching into fluids being warmed by these devices, which may reach toxic levels.

The notification identifies populations at special risk, and provides advice on flow rates.

One of the recommendations is to use 0.9% saline as the preferred fluid, instead of ‘balanced electrolyte solutions such as lactated Ringer’s’. However, this should be weighed against the evidence of risks of hyperchloraemia, metabolic acidosis and acute kidney injury using saline solution. Balanced electrolyte solutions, such as Hartmann's solution (lactated Ringer’s) or Plasma-Lyte, may reduce these risks.

For further information, see the Therapeutic Goods Administration Australia System for Australian Recall Actions entry. Additional information is also available via the Food and Drug Administration US Urgent Voluntary Recall

Update 15 September 2022: please note also the previous recall of another manufacturer's fluid warming system due to aluminium leaching, in our Safety alert of 6 March 2019.

Last updated 09:08 16.09.2022