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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 (IIS) 2 07/13/2022 FEI # 3014732157
Ivenix, Inc.
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), Large Volume Pump, Model No. LVP-0004 1 04/18/2023 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
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 2 03/11/2024 FEI # 3014732157
Fresenius Kabi USA, LLC
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 2 03/11/2024 FEI # 3014732157
Fresenius Kabi USA, LLC
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. 1 04/11/2024 FEI # 3014732157
Fresenius Kabi USA, LLC
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product ... 1 09/04/2024 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
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