Recall Z-2234-2025

Fresenius Kabi USA, LLC · initiated June 24, 2025

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.

Codes / lots: Product Code: SET-0021-25. UDI-DI: 00811505030108. Lot Codes: FA24K25146, FA24K25153.

Reason for recall

Potential for external cassette leaks

FDA-determined cause: Process design

Action taken

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.

Details

Recall number
Z-2234-2025
Initiated
June 24, 2025
Posted by FDA
August 1, 2025
Product code
FRN – Pump, Infusion
Quantity
35,925 units
Distribution
US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Recalling firm
Fresenius Kabi USA, LLC, North Andover, MA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2232-2025 Class IILVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty…Potential for external cassette leaks 06/24/2025Open, Classified
Z-2233-2025 Class IILVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty…Potential for external cassette leaks 06/24/2025Open, Classified
Z-2235-2025 Class IILVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site…Potential for external cassette leaks 06/24/2025Open, Classified