LVP Blood Products Administration Set Recalled for Potential Cassette Leaks
Fresenius Kabi USA recalled 14,280 units of its LVP Blood Products Administration Set due to potential external cassette leaks. The sets were distributed nationwide to healthcare facilities.
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: This is a Class II recall of a medical device used in critical care with potential for external cassette leaks. No illnesses, injuries, or deaths have been reported. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Fresenius Kabi USA, LLC is recalling LVP Blood Products Administration Sets (Product Code SET-0014-20, a medical device used for blood product administration) due to potential for external cassette leaks.
The recall affects approximately 14,280 units that were distributed nationwide in CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, and WI. Affected lot codes are FA24K05023, FA24L02010, FA24L04198, and FA24L04214. The product has UDI-DI: 00811505030030.
This is a Class II recall issued by the U.S. Food and Drug Administration.
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
- Hazard
- cassette-leak
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.
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