BEUDAMED
    FDA Enforcement Class I Ongoing

    Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Item Number 949000224; 4) FDS,135,NV,MICRO-CHAMBER,W/FILTER,RED, Item Number 949000221; 5) FDS,135,NV,MICRO-CHAMBER,W/FILTER,YELLOW, Item Number 949000223

    Recall: Z-0764-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0764-2025
    Event ID
    95988
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2025
    Initiation Date
    December 16, 2024
    Classification Date
    January 15, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Item Number 949000224; 4) FDS,135,NV,MICRO-CHAMBER,W/FILTER,RED, Item Number 949000221; 5) FDS,135,NV,MICRO-CHAMBER,W/FILTER,YELLOW, Item Number 949000223

    Reason

    Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.

    Code Info

    1)99000069UDI-D:10193489069587(each)30193489069581(case), Lot Number:0000128741; 2)99000069UDI-D:10193489069587(each)30193489069581(case), Lot Number:0000134505; 3)99000069UDI-D:10193489069587(each)30193489069581(case), Lot Number:0000133893; 4)99000069UDI-D:10193489069587(each)30193489069581(case), Lot Number:0000135769; 5)99000069UDI-D:10193489069587(each)30193489069581(case), Lot Number:0000139596; 6)949000222UDI-D:10197344018550(each)30197344018554(case), Lot Number:0000133018; 7)949000224UDI-D:10197344018642(each)30197344018646(case), Lot Number:0000136573; 8)949000221UDI-D:10197344018567(each)30197344018561(case), Lot Number:0000133036; 9)949000223UDI-D:10197344018543(each)30197344018547(case), Lot Number:0000133031;

    Distribution

    US Nationwide Distribution

    Quantity

    13,600 units