Fresenius Kabi USA, LLC Recalls
17 recalls on record in the United States
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (
Lack of Assurance of Sterility
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Fresenius Kabi USA, LLC recalls 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL
Lack of Assurance of Sterility
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Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg
Lack of Assurance of Sterility
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Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL
Lack of Assurance of Sterility
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Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (
Lack of Assurance of Sterility
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Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg
Lack of Assurance of Sterility
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Fresenius Kabi USA, LLC recalls 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50
Lack of Assurance of Sterility
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Fresenius Kabi USA, LLC recalls 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL)
Lack of Assurance of Sterility
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Fresenius Kabi USA, LLC recalls 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100
Lack of Assurance of Sterility
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Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg
Lack of Assurance of Sterility
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Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL)
Lack of Assurance of Sterility
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Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dick
Lack of Assurance of Sterility
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Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg
Lack of Assurance of Sterility
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Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg
Lack of Assurance of Sterility
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Fresenius Kabi USA, LLC recalls The Large Volume Pump (LVP) of the Ivenix Infusion System (I
Potential for the Cassette Loading Lever to break.
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Fresenius Kabi USA, LLC recalls LVP software of the Ivenix Infusion System (IIS); Product Co
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
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Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump, Model Numbe
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
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