Ivenix, Inc. recallZ-2232-2025 · Fresenius Kabi USA, LLC · initiated Jun 24, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Kabi USA, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for external cassette leaks
FDA root cause category: Process design
What the company is doing
Fresenius Kabi notified consignees on about 06/24/2025 via telephone call and followed up with a letter. Consignees were instructed to discontinue use and distribution immediately, quarantine any affected units on hand, notify users of the issue, and complete and return the Customer Reply Form. If affected units were further distributed, consignees were instructed to notify those customers. If Affected units were on hand, consignees were instructed to either destroy or arrange for their return. Replacement of affected units can be arranged.
Recall details
- Recall number
- Z-2232-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 24, 2025
- Posted by the FDA
- Aug 1, 2025
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 19,225 units
- Product code
- FRN
- FDA submissions
- K183311
- Distribution
- US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Product description
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Code information (models, lots, serial numbers)
Product Code: SET-0013-25. UDI-DI: 00811505030054. Lot Codes: FA24I26149, FA24I30133, FA24I30141, FA24J01131, FA24J01149.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ivenix, Inc. SET-0013-1Fresenius Kabi AG · Set, Administration, Intravascular2 recalls91 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K183311 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Ivenix Infusion System LVP-0004Fresenius Kabi AG · Pump, Infusion7 recalls2 deaths4,328 reports
- Ivenix Infusion System 030-0028-08Fresenius Kabi AG · Pump, Infusion7 reports
- Ivenix Infusion System 030-0027-06Fresenius Kabi AG · Infusion Safety Management Software3 reports
- Ivenix Infusion System 030-0028-07Fresenius Kabi AG · Pump, Infusion2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97165).
- Z-2233-2025 · Open, ClassifiedLVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
- Z-2234-2025 · Open, ClassifiedLVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
- Z-2235-2025 · Open, ClassifiedLVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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