This recall involves 483 cases of the Ivenix Infusion System LVP Primary Administration Set manufactured by Fresenius Kabi USA, LLC. These medical devices, used for large volume infusions in clinical settings, were found to be incorrectly assembled, which can prevent the system from operating safely. This recall specifically affects 12,075 individual units distributed to healthcare facilities in several states.
The incorrect assembly of the administration set could lead to a malfunction during infusion therapy, potentially resulting in serious patient injury or the failure to deliver necessary medication.
Distributed in IL, MD, MI, OK, SC, TX, VA & WI.
Vial label for Famotidine Injection, USP 20 mg per 2 mL Lot: 6133194, 2 mL
Vial label for Famotidine Injection, USP 20 mg per 2 mL Lot: 6133388, 2 mL
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · FDA Press Release · Raw API Response
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