FDA-Device2018-03-21Class II
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
Hazard
Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.
Sold states
Worldwide Distribution - US, including the District of Columbia, Puerto Rico, and Canada.
Affected count
173,375
Manufactured in
711 Park Ave, Medina, NY, United States
Products
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0971-2018More Baxter Healthcare Corporation recalls
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- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT 5KIT AC recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Hillrom Volara P.Circuit 5Kit breathing device recalled for nebulizer cup leakage risk
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