Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004

Hazard

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.

Details from the source

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. Distribution: Domestic: CA, CO, NJ, WI, & UT. No foreign distribution. Quantity: 1,546 units 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, 2124300116, 2124300119, 2124300120, 2124300121, 2124300122, 2124300123, 2124300124, 2124300125, 2124300126, 2124300127, 2124300128, 2124300129, 2124300130, 2124300131, 2124300132, 2124300133, 2124300134, 2124300135, 2124300136, 2124300137, 2124300138, 2124300140, 2124300141, 2124300142, 2124300143, 2124300144, 2124300145, 2124300146, 2124300147, 2124300148, 2124300150, 2124300151, 2124300152, 2124300153, 2124300154, 2124300155, 2124300156, 2124300157, 2124300159, 2124300160, 2124300161, 2124300162, 2124300164,

UPC codes

00811505030320

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.