SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Pending LLM rewrite. Source: FDA_DEVICE Z-1121-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
The recalled product
- Product
- SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN 00085412498683
Distribution
Distributed nationwide across the United States.
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