BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1549-2025 · Initiated March 5, 2025

    Recall

    Recall Number
    Z-1549-2025
    Event Number
    96541
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    GEI
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 5, 2025
    Posted
    April 9, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    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.

    Action

    Medline issued a "Medline ReNewal IMMEDIATE ACTION REQUIRED" notice dated 3/5/2025, to its consignees on 03/05/2025 via USPS first class mail. The notice explained the issue, potential risk, and requested the following actions: REQUIRED ACTION: 1. Immediately check your stock for the affected item numbers and the affected lot numbers. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Upon receipt of your submitted response form, FedEx return label(s) will be provided. Even if you do not have any affected product, please complete and return the form, as indicated on the response form. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline ReNewal. For questions, please contact 866-359-1704 or [email protected].

    Distribution

    US Nationwide distribution

    Quantity

    224 units