Fresenius Kabi USA, LLC: Medical Device Recall in 2025 - (Recall #: Z-2232-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.

Product Classification:

Class II

Date Initiated: June 24, 2025

Date Posted: August 6, 2025

Recall Number: Z-2232-2025

Event ID: 97165

Reason for Recall:

Potential for external cassette leaks

Status: Ongoing

Product Quantity: 19,225 units

Code Information:

Product Code: SET-0013-25. UDI-DI: 00811505030054. Lot Codes: FA24I26149, FA24I30133, FA24I30141, FA24J01131, FA24J01149.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated