FDAClass IIAugust 6, 2025

LVP Blood Products Administration Set Dual-Inlet recall

LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.

Why was LVP Blood Products Administration Set Dual-Inlet recalled?

Potential for external cassette leaks

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
Recalling firm
Fresenius Kabi USA, LLC
Quantity
14,280 units
Distribution
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.
Recall date
August 6, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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