CLASS II ONGOING Device recall · Reported 8 Jan 2025 · FDA Enforcement Report
Baxter Sigma Spectrum Infusion Pump with Master Drug Library recalled
Baxter Healthcare is recalling Baxter Sigma Spectrum Infusion Pump with Master Drug Library (, distributed nationwide in the US. The recall was initiated on 19 Nov 2024 and the FDA has classified it as Class II.
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-0776-2025
- FDA event ID
- 95848
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Nov 2024
- FDA classified
- 27 Dec 2024
- Reported
- 8 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Infusion Pumps
Timeline
| 19 Nov 2024 | Recall initiated by company | |
| 27 Dec 2024 | Classified by FDA | +38 days |
| 8 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices were identified as released after repair without full testing being performed, which includes flow testing.
Product as listed by the FDA
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Where it was distributed
US Nationwide distribution in the states of AL, IN.
Questions about this recall
Why was it recalled?
Devices were identified as released after repair without full testing being performed, which includes flow testing.
Which lots are affected?
GTIN 00085412498683; Serial Number: 2153638
Where was it sold?
US Nationwide distribution in the states of AL, IN.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 95848| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Baxter Sigma Spectrum Infusion Pump with Master Drug Library recalled | Baxter Healthcare | Other | Nationwide |
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