| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-01809-1 |
| Product Name/Description |
Fluid Warming System and administration sets
Model names: Level 1 Fluid Warmer, Level 1 Fluid Warming System, Level 1 Normothermic I.V. Fluid Administration Set, NORMOFLO Fluid Warmer and NORMOFLO Irrigation Warming Set
Multiple model numbers
ARTGs 241980, 246532, 262481 and 246052 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/09/2021 |
| Responsible Entity |
|
| Reason/Issue |
Smiths Medical has become aware that use of Fluid Warming Devices with uncoated aluminium heating elements under certain circumstances may result in exposure to harmful levels of aluminium. Potentially higher aluminium leaching may occur when using the flow rates of 30mL/min with certain solutions and blood products and with longer duration of use.
To date, Smiths Medical has identified no complaints, or reports of injury or death, associated with this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Smiths Medical are advising customers that potentially higher aluminium leaching from the devices may occur when using lower flow rates (e.g., 30mL/min), with certain solutions and blood products, and longer duration of use. Normal saline is preferred instead of balanced electrolyte solutions such as lactated Ringer's solution when clinically possible.
Customers are also advised to secure or display a provided placard (provided to impacted customers by the sponsor) with the printed instructions near each device and evaluate the benefits and risks of using the device versus the patient condition.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 654 949 - Customer Service Department - Smiths Medical |