[pending] Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Versio
Pending LLM rewrite. Source: FDA_DEVICE Z-1368-2026.
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
Pumps were released without full testing being performed, including occlusion alarm testing.
The recalled product
- Product
- Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
- 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 (6)
- Lot Code: GTIN 00085412610900
- Serial Numbers 3815663
- 3823468
- 3824743
- 3825234
- and 3825599
Distribution
Distribution scope not specified by the agency.
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