| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00535-1 |
| Product Name/Description |
Level 1 Fast Fluid Flow Fluid Warmers and Level 1 NORMOFLO Irrigation Fluid Warmers
Model numbers: H-1200, H1100
SKUs: H-1200-EN-230V-AU, H-1100-INT-230
ARTG 395850
(Smiths Medical Australasia Pty Ltd - Convection blood/fluid warmer, high-flow) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
Smiths Medical has become aware of two problems related to the Level 1 Fast Flow Fluid Warmers and Level 1 NORMOFLO Irrigation Fluid Warmers:
1. The return tube assembly inside the warmers may exhibit stress cracking that can propagate over time and potentially result in leaking recirculating fluid. Leaking recirculating fluid may potentially damage other components within the warmer, such as the printed circuit board.
2. The cable inside the warmers that connects to the external on/off switch may potentially exhibit delamination of insulation which may propagate over time and may lead to corrosion and a break in the electrical circuit. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Users should:
1: Prior to use, confirm that the device powers on and passes all the alarm tests outlined in the Setup for Use section in the Operator’s Manual and customer letter. If the device fails during these alarm tests or does not power on, remove the device from service and submit a complaint to Smiths Medical.
2: Users should have back up devices such as manual pressure cuffs or additional Level 1 Fast Flow Fluid Warmer or Level 1 Normoflo Irrigation Fluid Warmer available for emergency situations.
Smiths Medical is in the process of correcting these issues and will contact customers as soon as the solutions are available for implementation onto their devices. |
| Contact Information |
1800 654 949 - Customer Service |