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U.S. Department of Health and Human Services

Medical Device Recalls
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11 to 14 of 14 Results
510(K) Number: K133801
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Product Description
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Recall
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FDA Recall
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Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2. 1 01/29/2022 FEI # 1417572
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX 2 12/27/2024 FEI # 1417572
Baxter Healthcare Corporation
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX 1 03/06/2025 FEI # 1417572
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX 1 07/17/2025 FEI # 1417572
Baxter Healthcare Corporation
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