Fresenius Kabi USA recalls 483 LVP Primary Infusion Sets for the IVENIX infusion system nationwide in the United States. The recall cites incorrect assembly of a specific lot. Hospitals and clinicians should stop using the affected sets immediately and follow the manufacturer’s recall instructions.
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 IVENIX infusion system uses LVP primary administration sets to deliver fluids and medications in hospital and clinical settings. The recall affects a specific lot and lot-specific assembly.
Incorrect assembly of the LVP Primary Administration Set can disrupt flow or connections, potentially leading to patient injury.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals and clinics must verify lots and halt use of affected sets. Providers may experience service delays while replacements are issued.
Lot numbers and product codes appear on packaging labels and tubing set boxes; UDI is on label.
4-8 weeks for refunds or replacements after verification.
Keep recall notices, photos of labels, packing, correspondences, and replacement receipts for records.
Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126. Distribution: US nationwide in IL, MD, MI, OK, SC, TX, VA, WI. Quantity: 483 cases (12,075 eaches). Sold/ sold to: Unknown. Manufacturer: Fresenius Kabi USA. Price: Unknown.
No injuries or incidents have been reported.
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