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Recall Observatory FDA recall evidence

Device product

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

Z-2232-2025

June 24, 2025

Class II

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 97165
Status
Ongoing
Classification
Class II
Quantity
19,225 units
Official record key
device-enforcement:Z-2232-2025

Official wording

Reason: Potential for external cassette leaks

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for external cassette leaks