Fresenius Kabi USA, LLC 2025-06-18 Health critical FDA
Health · FDA · Recall #FDA-Z-1869-2025
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing,… Recall
Issued June 18, 2025 · Fresenius Kabi USA, LLC
In June 2025, Fresenius Kabi USA, LLC recalled the IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing,…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Fresenius Kabi USA, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Fresenius Kabi USA, LLC
- Category
- Health
- Recall date
- June 18, 2025
- Units affected
- Not reported
- Sold at
- US distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA & WI.
- Recall number
- FDA-Z-1869-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Fresenius Kabi USA, LLC has 16 recalls in our database, including 6 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.