BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R

    Recall: Z-1549-2025 · Reported April 16, 2025

    Enforcement

    Recall Number
    Z-1549-2025
    Event ID
    96541
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 16, 2025
    Initiation Date
    March 5, 2025
    Classification Date
    April 9, 2025
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R

    Reason

    Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

    Code Info

    UDI/DI 10080196415106, Lot Numbers: 506549, 508766, 509420, 512036, 512983, 514060, 514709, 516475, 516802, 517626, 518478, 518961, 519248, 519259, 519411, 519412, 519413, 519966, 519969, 520277, 522144, 522145, 527110, 527112, 528454, 528458, 528584, 531021, 531022.

    Distribution

    US Nationwide distribution

    Quantity

    224 units