Agency classClass IIOur severity:High FDA (Devices)·Z-2234-2025·Announced 2025-08-06

LVP primary administration sets have potential for external cassette leaks

LVP Primary Administration Sets, Single Outlet Low Sorbing, are being recalled because of the potential for external cassette leaks. 35,925 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Risk-of-harm product: a leak in a set used to administer infused fluids, with no injury reported in the source.

Plain-English summary

The LVP Primary Administration Set, Single Outlet Low Sorbing, quantity 25, product code SET-0021-25, UDI-DI 00811505030108, is being recalled. The action covers 35,925 units from lot codes FA24K25146 and FA24K25153.

The stated reason is the potential for external cassette leaks. The FDA classified the action as Class II. The source does not report any injury having occurred.

Distribution was nationwide in the United States, including California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Massachusetts and Maryland among other states. The sets are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the product code, UDI-DI and lot codes above and follow the instructions issued by the manufacturer.

The recalled product

Product: LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
Manufacturer: Fresenius Kabi USA, LLC
Category: Medical Device — Administration set
Hazard: cassette-leak
infusion-set
fluid-leak
class-ii
Affected units: 35,925

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Fresenius Kabi USA, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Fresenius Kabi USA, LLC

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Same hazard · cassette leak