Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- Fresenius Kabi USA
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Fresenius Kabi USA
- Product type
- Infusion Set (LVP Primary Administration Set)
- Model numbers
- SET-0032-25, UDI: 00811505030214, Lot No. FA25B03126.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 3, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
What You Should Do
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
About This Product
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.
Why This Is Dangerous
Incorrect assembly of the LVP Primary Administration Set can disrupt flow or connections, potentially leading to patient injury.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals and clinics must verify lots and halt use of affected sets. Providers may experience service delays while replacements are issued.
Practical Guidance
How to identify if yours is affected
- Check product code SET-0032-25 on the device or packaging
- Check Lot FA25B03126 on labels or packaging
Where to find product info
Lot numbers and product codes appear on packaging labels and tubing set boxes; UDI is on label.
What timeline to expect
4-8 weeks for refunds or replacements after verification.
If the manufacturer is unresponsive
- Document all contact attempts and keep copies of recall notices.
- Escalate to hospital safety officers or risk management if the manufacturer is slow to respond.
How to prevent similar issues
- Buy from authorized distributors; verify recall status before installation.
- Maintain an up-to-date inventory of infusion sets and cross-check lot numbers before use.
- Monitor for any recall updates from FDA or the manufacturer.
Documentation advice
Keep recall notices, photos of labels, packing, correspondences, and replacement receipts for records.
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Product Details
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.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 12,075 total units (eaches)
- Lot FA25B03126
- Product Code SET-0032-25
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Safety Guide
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