Important Safety Alerts

Medical device manufacturer, Smiths Medical, has issued a medical device safety alert concerning the following models of LEVEL 1 Fast Flow Fluid Warming and Irrigation System Disposables:

• Level 1 Fluid Warmer [Model Number: H-1000, H-500]
• Level 1 Fluid Warming System [Model Number: H-1025, H-1028, H-1200]
• Level 1 Normothermic I.V. Fluid Administration Set [Model Number: D-100, D-300, D-50, D-60HL, DI-100, DI-300, DI-50, DI-60HL, D-70, DI-70]
• NORMOFLO Fluid Warmer [Model Number: H-1100, H-1129]
• NORMOFLO Irrigation Warming Set [Model Number: IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700]

The manufacturer has investigated the potential for aluminum ion leaching in its fluid warming products and is providing users with operating parameters to ensure safe operation of the devices under certain clinical use conditions. Exposure to toxic levels of aluminum could potentially lead to serious injury or possibly death depending on the treatment being administered and the patient’s condition. The manufacturer advised that the patient populations especially at risk include pediatric patients (particularly neonates and infants) pregnant women, elderly, patients with poor renal function or on dialysis. According to the manufacturer, it has not identified complaints, or reports of injury or death, associated with this issue.

The manufacturer is advising users to identify their product and also follow the instructions as mentioned in the customer letter to mitigate the risk of exposure to aluminum accordingly.

According to the manufacturer, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 19 Aug 2021