FDA Medical devices recall ·
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1869-2025
- Date
- (initiated May 12, 2025)
- Company / brand
- Fresenius Kabi USA, LLC
50 High St Ste 50, North Andover, MA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 14,280 units (724 cases)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. SET-0014-20; UDI 20811505030034; Lot No. FA24K05015.
Distribution
US distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA & WI.
States: California Colorado Delaware Georgia Illinois Maryland Michigan Minnesota Mississippi North Carolina New Jersey Nevada Oklahoma South Carolina Texas Virginia Washington Wisconsin
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1869-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.