Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004

Summary

The FDA issued a Class I for Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004 by Fresenius Kabi USA, LLC. Reason: Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusi.

Details

Product Description

Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004

Lot/Code Info: UDI-DI: 00811505030320; Serial No.: 2118200008, 2118200011, 2119300411, 2119300412, 2119300414, 2119300415, 2119300416, 2119300417, 2119300418, 2119300421, 2119300422, 2119300424, 2119300426, 2119300427, 2119300428, 2119300429, 2119300430, 2119300431, 2119300432, 2119300434, 2119300435, 2119300436, 2119300437, 2119300438, 2119300439, 2119300440, 2119300442, 2124300049, 2124300051, 2124300052, 2124300053, 2124300054, 2124300058, 2124300059, 2124300060, 2124300061, 2124300062, 2124300063, 2124300064, 2124300065, 2124300066, 2124300068, 2124300069, 2124300070, 2124300072, 2124300074, 2124300075, 2124300076, 2124300077, 2124300078, 2124300080, 2124300082, 2124300083, 2124300084, 2124300085, 2124300086, 2124300087, 2124300089, 2124300090, 2124300091, 2124300093, 2124300094, 2124300096, 2124300097, 2124300099, 2124300100, 2124300101, 2124300102, 2124300103, 2124300104, 2124300106, 2124300107, 2124300108, 2124300109, 2124300110, 2124300111, 2124300112, 2124300113, 2124300114, 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Quantity Affected: 1,546 units

Reason for Recall

Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-03-10

Company