Fresenius Kabi USA, LLC medical device recall: IVENIX INFUSION SYSTEM LVP Blood Products Administration Set
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96880
- Recall initiated
- May 12, 2025
- Classified by FDA
- Jun 6, 2025
- Posted in Enforcement Report
- Jun 18, 2025
- Recalling firm
- Fresenius Kabi USA, LLC
- Firm location
- North Andover, MA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
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 the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on May 12, 2025. FDA classified it 25 days later, on Jun 6, 2025. Distribution reported by FDA: US distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA & WI. Fresenius Kabi USA, LLC has 67 recalls in our records.
Recalled products (1)
Z-1869-2025 Class I Ongoing
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Codes / lots: Model No. SET-0014-20; UDI 20811505030034; Lot No. FA24K05015.
Quantity: 14,280 units (724 cases)
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96880
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.