Fresenius Kabi USA, LLC is recalling 417,580 LVP Administration Sets due to the potential for external leaks at the cassette. These sets are used with infusion pumps to deliver fluids, medications, or blood products to patients in clinical settings. Although no injuries have been reported, a leak could result in under-infusion, loss of sterile medication, or the entry of air into the fluid path. The affected products were distributed to hospitals and medical facilities across 21 states between June and July 2025.
The external cassette leaks can cause a failure in the proper delivery of life-sustaining medications or fluids. This poses a risk of under-infusion to the patient and increases the potential for environmental contaminants to enter the fluid line.
Recall #: Z-2232-2025
Recall #: Z-2233-2025
Recall #: Z-2234-2025
Recall #: Z-2235-2025
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.
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Sources: FDA iRES · Raw API Response
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