BEUDAMED
    FDA Recall Open, Classified

    Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit

    Recall: Z-1173-2025 · Initiated January 3, 2025

    Recall

    Recall Number
    Z-1173-2025
    Event Number
    96163
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Packaging
    Initiated
    January 3, 2025
    Posted
    February 14, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit

    Reason

    Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.

    Action

    Medline issued an URGENT MEDICAL DEVICE RECALL on 01/03/2025 via email and US Mail, first class. The notice explained the issue, the low probability of clinical risk, and requested the consignee perform the following actions: identify and quarantine all affected product and respond to the notice using the website. Those consignees with affected product will receive labels to affix to the package stating not to use the affected component. All those who further distributed or transferred the product were directed to notify those to whom the product was distributed..

    Distribution

    US: CA

    Quantity

    36 units