LVP Blood Products Set (Fresenius Kabi) – Cassette Leak (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
Brand
Fresenius Kabi USA, LLC
Lot Codes / Batch Numbers
Product Code: SET-0014-20. UDI-DI: 00811505030030. Lot Codes: FA24K05023, FA24L02010, FA24L04198, FA24L04214.
Products Sold
Product Code: SET-0014-20. UDI-DI: 00811505030030. Lot Codes: FA24K05023, FA24L02010, FA24L04198, FA24L04214.
Fresenius Kabi USA, LLC is recalling LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product due to Potential for external cassette leaks. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for external cassette leaks
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026