BEUDAMED
    FDA Recall Open, Classified

    MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

    Recall: Z-1889-2025 · Initiated April 23, 2025

    Recall

    Recall Number
    Z-1889-2025
    Event Number
    96809
    Firm
    Mozarc Medical US LLC
    FEI Number
    3030574705
    Product Code
    MSD
    Status
    Open, Classified
    Root Cause
    Packaging
    Initiated
    April 23, 2025
    Posted
    May 30, 2025
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    Description

    MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

    Reason

    Potential breach of sterile barrier packaging.

    Action

    An URGENT: MEDICAL DEVICE RECALL notification dated April 2025 was mailed to consignees on 4/23/25. This notification recommends that clinicians follow facility-specific policies and procedures for routine assessment of the hemodialysis access device for patency, function, and efficacy, as well as for monitoring patient status. Consignees are instructed to immediately quarantine and discontinue use of affected devices in inventory. Consignees are to complete the electronic Customer Confirmation form to facilitate obtaining a Return Goods Authorization number for recalled devices to be returned for credit or replaced. Product purchased through a distributor can be arranged through the distributor. Consignees with any questions about the Customer Confirmation form can contact IQVIA by phone at 1-256-680-9942 or by email at [email protected]. Consignees with questions about the recall can contact Medtronic Customer Care at 877-211-1850.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada & Mexico.

    Quantity

    95,938 units