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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 22 Results
510(K) Number: K183311
 
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IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh ... 1 06/06/2025 FEI # 3014732157
Fresenius Kabi USA, LLC
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, D... 1 12/03/2025 FEI # 3014732157
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS) 2 07/13/2022 FEI # 3014732157
Ivenix, Inc.
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in ou... 1 02/04/2025 FEI # 3014732157
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration o... 1 12/16/2025 FEI # 3014732157
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005. 2 01/12/2026 FEI # 3014732157
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 1 10/06/2022 FEI # 3014732157
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion... 1 09/26/2024 FEI # 3014732157
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW... 2 09/25/2023 FEI # 3014732157
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 1 12/20/2023 FEI # 3014732157
Fresenius Kabi USA, LLC
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