The Recall Desk
HighFDA (Devices)·Z-2233-2025·Announced 2025-08-06

LVP blood administration sets have potential for external cassette leaks

LVP Blood Products Administration Sets are being recalled because of the potential for external cassette leaks. 14,280 units are affected.

What this means for you

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 blood products, with no injury reported in the source.

Plain-English summary

The LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, quantity 20, product code SET-0014-20, UDI-DI 00811505030030, is being recalled. The action covers 14,280 units across the lot codes listed in the recall notice, including FA24K05023 and FA24L02010.

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 Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
Manufacturer
Fresenius Kabi USA, LLC
Category
Medical Device — Administration set
Hazard
Affected units
14,280

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 (4)

  • Product Code: SET-0014-20. UDI-DI: 00811505030030. Lot Codes: FA24K05023
  • FA24L02010
  • FA24L04198
  • FA24L04214.

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 →

Related recalls

Same manufacturer · Fresenius Kabi USA, LLC

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Same hazard · cassette leak

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