BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2233-2025 · Initiated June 24, 2025

    Recall

    Recall Number
    Z-2233-2025
    Event Number
    97165
    Firm
    Fresenius Kabi USA, LLC
    FEI Number
    3014732157
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    June 24, 2025
    Posted
    August 1, 2025
    Address
    50 High St, Ste 50, North Andover, MA, 01845-2620

    Description

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

    Reason

    Potential for external cassette leaks

    Action

    Fresenius Kabi notified consignees on about 06/24/2025 via telephone call and followed up with a letter. Consignees were instructed to discontinue use and distribution immediately, quarantine any affected units on hand, notify users of the issue, and complete and return the Customer Reply Form. If affected units were further distributed, consignees were instructed to notify those customers. If Affected units were on hand, consignees were instructed to either destroy or arrange for their return. Replacement of affected units can be arranged.

    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.

    Quantity

    14,280 units