Fresenius Kabi USA, LLC is recalling 15,862 units of the Ivenix Infusion System (IIS) Large Volume Pump, specifically Model Number LVP-0004. The recall was initiated because the pump may trigger downstream occlusion alarms—which indicate a blockage in the flow—when used at low flow rates with an added check valve in the administration set. These alarms can cause the pump to stop, potentially interrupting the delivery of critical medications to patients. Consumers should contact the manufacturer or their medical distributor to arrange for a return, replacement, or correction of the device.
The device may incorrectly identify a blockage and stop the infusion when operating at low flow rates with a check valve. This can lead to unexpected interruptions in treatment or delays in medication delivery, which may pose a risk to patient health depending on the urgency of the therapy.
Firm initiated voluntary recall for return, replacement, or correction.
Units affected: 15,862 units.
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.
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Sources: FDA iRES · FDA Press Release · Raw API Response
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