Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28376 |
| Brand Name: | Smiths Medical ASD (MMSP) Fluid Warmer |
| Model: | H-1000, H-500, H-1028, H-1200 |
| Affected: | |
| 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 |
| Brand Name: | Smiths Medical ASD (MMSP) Fluid Warming Set |
| Model: | H-1100,H-1025, H-1129 |
| Affected: | |
| 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 |
| Brand Name: | Smiths Medical ASD (MMSP) Irrigation Warming Set |
| Model: | IR-40, IR-500, IR-600, IR-700, IRI-600, IRI-600B,IR-700 |
| Affected: | |
| 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 has investigated the potential for aluminum ion leaching in Smiths Medical fluid warming product sand is providing users with operating parameters to ensure safe operation of the devices under certain clinical use conditions. 11/02/2022 Update: The EU Responsible Notified Body completed their review of the Affected Product Models of LEVEL 1 Fast Flow Fluid Warming and Irrigation System devices and consumables listed on page 1 and has temporarily suspended the CE mark for the affected products until further notice. This suspension applies to all jurisdictions where the CE mark is used for regulatory approvals, this includes Australia. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 24/9/2021 |
