Fresenius Kabi USA, LLC Recalls
25 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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Fresenius Kabi USA, LLC recalls Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, R
Failed Impurities/Degradations Specifications
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Fresenius Kabi USA, LLC recalls Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 10
Presence of Particulate Matter: Hair was found in products
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Fresenius Kabi USA, LLC recalls Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20
Presence of Particulate Matter: Hair was found in products
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Fresenius Kabi USA, LLC recalls Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per
Presence of Particulate Matter: Hair was found in products
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Fresenius Kabi USA, LLC recalls Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50
Presence of Particulate Matter: Hair was found in products
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Fresenius Kabi USA, LLC recalls Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL)
Presence of Particulate Matter: Hair was found in product
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Fresenius Kabi USA, LLC recalls Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL)
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
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Fresenius Kabi USA, LLC recalls Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
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