Z-2234-2025 Class II Ongoing
FDA device recall Z-2234-2025 was initiated by Fresenius Kabi USA, LLC on June 24, 2025 and is designated Class II. Reason for recall: Potential for external cassette leaks The recall status is ongoing. Affected quantity: 35,925 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 6, 2025
- Initiation Date
- June 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,925 units
Product Description
LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
Reason for Recall
Potential for external cassette leaks
Distribution Pattern
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.
Code Information
Product Code: SET-0021-25. UDI-DI: 00811505030108. Lot Codes: FA24K25146, FA24K25153.