CLASS I ONGOING Device recall · Reported 12 Mar 2025 · FDA Enforcement Report
Baxter Sigma Spectrum Infusion System (V6 Platform) recalled
Baxter Healthcare is recalling Baxter Sigma Spectrum Infusion System (V6 Platform), distributed nationwide in the US. The recall was initiated on 5 Feb 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1253-2025
- FDA event ID
- 96289
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 5 Feb 2025
- FDA classified
- 6 Mar 2025
- Reported
- 12 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 5 Feb 2025 | Recall initiated by company | |
| 6 Mar 2025 | Classified by FDA | +29 days |
| 12 Mar 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Product as listed by the FDA
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
Where it was distributed
US: Nationwide
Questions about this recall
Why was it recalled?
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Which lots are affected?
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
Where was it sold?
US: Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96289| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Baxter Spectrum IQ Infusion System with Dose IQ Safety recalled | Baxter Healthcare | Device Malfunction | Nationwide |
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