[pending] SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Pending LLM rewrite. Source: FDA_DEVICE Z-1121-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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