FDA Class I Recall: Potential risk of aluminum leaching with use of certain fluid warmer devices

Sept. 16, 2021

The U.S. Food and Drug Administration (FDA) is reminding and has issued a number of recalls for healthcare providers about the use of certain fluid warmers and the potential for aluminum leaching and exposing the patient to high levels of aluminum. Based on information reviewed by the FDA, aluminum leaching may occur when the fluid warmer is designed with an aluminum heating element where the heated aluminum is in direct contact with the fluids or blood products being administered to a patient.

The FDA has identified the devices listed in the table below as having this type of design. Three original equipment manufacturers (Eight Medical International BV, Smisson Cartledge Biomedical and Smith Medical) provided revised instructions for use for these devices, a type of voluntarily recall action, which were initiated on the dates shown. Users who did not purchase devices from these original equipment manufacturers may not be aware of the revised instructions. A fourth original equipment manufacturer (Vyaire Medical) voluntarily removed its product from the market.

The FDA recommends healthcare providers be aware that aluminum leaching from some fluid warmers may occur when both of the following conditions are present:

  • Lower flow rates
  • Higher warming temperatures
  • Certain fluids, including balanced electrolyte solutions, may leach more aluminum than other solutions (such as Lactated Ringers solutions) 
  • Longer duration of use.

Be aware that exposure to high levels of aluminum may result in adverse clinical effects and symptoms such as:

  • Bone, muscle pain and muscle weakness
  • Blood and metabolic derangements (such as increased levels of calcium or interference with iron absorption leading to anemia)
  • Neurological effects (such as altered consciousness, seizures and coma).

Conduct a clinical benefit-risk analysis before using a fluid warmer which has an aluminum heating element and is in direct contact with the fluids or blood products. To mitigate potential harm from aluminum leaching:

  • When possible, avoid using these fluid warmers in high-risk patient populations including those with poor renal function, neonates, infants, pregnant mothers and the elderly because exposure to small amounts of aluminum may lead to toxicity. 
  • If available, use alternative therapies to maintain patient temperature, such as an alternative fluid warmer which uses a different design, or a warming blanket.

For specific information on steps to take to mitigate aluminum leaching, review the applicable recall notices from each company (see table above) or contact the manufacturer directly for more information.

Fluid warmers are generally used to warm intravenous (IV) fluids and blood products to maintain normal temperature or prevent hypothermia and can also be used during surgical procedures for surgical site irrigation or lavage in different areas of the body. These devices have different clinical uses which impact their device design and specifications, including flow rate and heating capabilities, duration of use and intended patient populations.

Data from in vitro testing with uncoated fluid warmers indicates that in certain cases (for example, lower flow rates, higher temperatures, certain infusates such as balanced electrolyte solutions, and longer duration of use), the quantity of aluminum released from these devices may significantly exceed the FDA-derived threshold value of 25 mcg/L, which was established for small and large volume parenteral administration. The dissolving (elution) of aluminum into the body may lead to systemic aluminum exposure and subsequent toxicity under some clinical situations and with high-risk patient populations including neonates, infants, pregnant mothers and the elderly as well as patients with poor renal function or on dialysis. Literature reports describe neurotoxicity concomitant with increased aluminum serum levels.

For example, manifestations of encephalopathy after irrigation with solutions containing aluminum have been reported at serum concentrations as low as 17, 22, or 40 mcg AL/L blood.

Numerous FDA Class I recalls are being released:

Eight Medical International Recalls Recirculator 8.0 Disposable Lavage Kits due to Potential Exposure to High Levels of Aluminum   

Smisson-Cartledge Biomedical, LLC Recalls ThermaCor 1200 Disposable Sets for Risk of Patient Contact to Aluminum 

Level 1 Fast Flow Fluid Warming System, Smiths Medical NORMOFLO Fluid Warmer and Level 1 Normothermic I.V. Fluid Administration Set

FDA warning