FDA recall Z-2233-2025

Fresenius Kabi USA, LLC · Class II · device

Product

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

Reason for recall

Potential for external cassette leaks

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.

Key facts

Status
Ongoing
Initiation date
2025-06-24
Report date
2025-08-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2233-2025