FDA Medical devices recall ·
LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25) recall
- Recall number
- Z-2234-2025
- Date
- (initiated June 24, 2025)
- Company / brand
- Fresenius Kabi USA, LLC
50 High St Ste 50, North Andover, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 35,925 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
Why was it recalled?
Potential for external cassette leaks
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product Code: SET-0021-25. UDI-DI: 00811505030108. Lot Codes: FA24K25146, FA24K25153.
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.
States: California Colorado Delaware Florida Georgia Idaho Illinois Massachusetts Maryland Michigan Minnesota Mississippi New Jersey Nevada Oklahoma Oregon South Carolina Texas Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2234-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.