Ivenix, Inc. recallZ-1869-2025 · Fresenius Kabi USA, LLC · initiated May 12, 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
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
FDA root cause category: Under Investigation by firm
What the company is doing
Consignees received an "URGENT - VOLUNTARY RECALL" notification via email dated 5/11/25. This notification instructs consignees to discontinue use and distribution of affected devices immediately. Consignees are to check their inventory for affected devices and place them in quarantine until product can be returned for replacement. The provided recall notification is to be distributed to users of the affected devices. Consignees are instructed to return the completed Customer Reply Form via fax or email to facilitate return of affected devices for replacement. Consignees with any questions can contact Fresenius Kabi by phone at 855-354-6387x1 or by email at [email protected].
Recall details
- Recall number
- Z-1869-2025
- Status
- Open, Classified
- Initiated by the company
- May 12, 2025
- Posted by the FDA
- Jun 6, 2025
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 14,280 units (724 cases)
- Product code
- FPA
- FDA submissions
- K183311
- Distribution
- US distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA & WI.
Product description
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Code information (models, lots, serial numbers)
Model No. SET-0014-20; UDI 20811505030034; Lot No. FA24K05015.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ivenix, Inc. SET-0014-1Fresenius Kabi AG · Set, Administration, Intravascular2 recalls93 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
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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