FDA Device recall Z-1253-2025
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
- FDA Device
- Class I
- ongoing
- Published 2025-03-12
On 2025-03-12 the FDA classified a Class I recall of Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX by Baxter Healthcare, citing there is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1253-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-02-05 |
| Published | 2025-03-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
Reason
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Identifiers
| code_info | UDI/DI 00085412091570, Serial Numbers: 704198, 728888, 751492, 758399, 758614, 761662, 763197, 766291, 772611, 773302,…UDI/DI 00085412091570, Serial Numbers: 704198, 728888, 751492, 758399, 758614, 761662, 763197, 766291, 772611, 773302, 775486, 778837, 785425, 793453, 795240, 798065, 814485, 818850, 826637, 850214, 850854, 851500, 854157, 855803, 863354, 870307, 873114, 876483, 877014, 877102, 889153, 896292, 900181, 906422, 907176, 912242, 913562, 927864, 938265, 958176, 962828, 963975, 965158, 974676, 981605, 982459, 984154, 986132, 986634, 989053, 993087, 994417, 994842, 995538, 997153, 1006359, 1011058, 1013925, 1014064, 1014529, 1014856, 1017150, 1017546, 1018229, 1018703, 1024109 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1253-2025%22
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