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U.S. Department of Health and Human Services

Medical Device Recalls
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CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, M... 1 05/05/2025 Smiths Medical ASD, Inc.
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH... 1 05/05/2025 Smiths Medical ASD, Inc.
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software 1 03/13/2025 CareFusion 303, Inc.
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software 1 03/13/2025 CareFusion 303, Inc.
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 1 03/06/2025 Baxter Healthcare Corporation
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX 1 03/06/2025 Baxter Healthcare Corporation
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in ou... 1 02/04/2025 Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 1 01/08/2025 Fresenius Kabi USA, LLC
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems:... 1 11/21/2024 ICU Medical, Inc.
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of ... 1 10/31/2024 Smiths Medical ASD Inc.

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