Fresenius Kabi USA recalled 12,075 infusion pump administration sets on November 3, 2025. The recall stems from incorrect assembly that poses a serious risk of patient injury. Healthcare providers and patients should stop using the devices immediately.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Fresenius Kabi USA, LLC or your healthcare provider for instructions. Notification method: E-Mail
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The recall involves the IVENIX Infusion System, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site. The affected product code is SET-0032-25, with UDI 00811505030214 and Lot No. FA25B03126. The product was distributed nationwide in the U.S. across multiple states.
The incorrect assembly of the LVP Primary Administration Set could result in serious patient injury. This issue has been classified as a Class I recall, indicating a high risk to patient safety.
No specific incident or injury counts have been reported at this time. However, the potential for serious patient injury exists due to the incorrect assembly of the devices.
Patients and healthcare providers should stop using the recalled infusion sets immediately. Follow the recall instructions provided by Fresenius Kabi USA, LLC. Contact your healthcare provider for further instructions.
For more information, contact Fresenius Kabi USA, LLC via their website or email. Additional details can be found at the FDA's enforcement report link.
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