LVP dual Y-site administration sets have potential for external cassette leaks

Plain-English summary

The LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site, quantity 25, product code SET-0032-25, UDI-DI 00811505030214, is being recalled. The action covers 348,150 units across the lot codes listed in the recall notice, including FA24J03137 and FA24J03145.

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, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.

Manufacturer

Fresenius Kabi USA, LLC

Category

Medical Device — Administration set

Hazard

• cassette-leak
• infusion-set
• fluid-leak
• class-ii

Is your product affected?

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

Distribution

Distributed nationwide across the United States.

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