Database updated: 18 November 2024
Safety Information
Medsafe Online Recall Database
Detail of Recall
Type of Product: | Device |
Medsafe Reference: | 29600 |
Brand Name: | Smiths Medical ASD (MMSP) Fluid Warmer |
Model: | |
Affected: | Affective product - H-1000, H-1025, H-1200 |
Software version: | |
Recalling Organisation: | Smiths Medical Australasia Pty Ltd c/o KPMG, KPMG Centre 18 Viaduct Harbour Avenue Auckland |
Contact Information: | 0800 444 200 |
Manufacturer: | Smiths Medical ASD Inc |
Issue: | The manufacturer implemented a design change to widen the hinge assembly on the Level 1 H-2 Pressure Chambers used with the Level 1 Fast Flow Fluid Warmers (Models H-1025 or H-1200) or added to the H-1000 model. The manufacturer has become aware that Level 1 H-2 Pressure Chambers with the wider hinge assembly can potentially impact the amount of pressure exerted onto the IV fluid bag while contained within the pressure chamber. This may result in decreased flow rate, stopped flow or residual fluid left within the IV bag. |
Recall action type: | Correction |
Recall action: | Manufacturer to issue advice regarding use |
Level of recall: | Hospital/Pharmacy/Laboratory |
Date Commenced: | 28/6/2022 |