BEUDAMED
    FDA Recall Open, Classified

    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;

    Recall: Z-0421-2026 · Initiated October 17, 2025

    Recall

    Recall Number
    Z-0421-2026
    Event Number
    97848
    Firm
    Mozarc Medical US LLC
    FEI Number
    3030574705
    Product Code
    NIE
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 17, 2025
    Posted
    November 4, 2025
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    Description

    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;

    Reason

    A potential issue with the seal integrity of header bag packaging.

    Action

    On October 17, 2025, URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Required Actions: 1. Immediately quarantine and discontinue use of unused affected product. 2. Please complete and return the Customer Response Form (Attachment 1), regardless of whether unused inventory is available. 3. If you have unused inventory, please contact Customer Care at 1-877-211-1850 or via email [email protected] to request an RGA. Please copy your local sales representative on this email. 4. Share this notice with those who need to be aware within your organization or to any organization including, but not limited to, surgeons, interventionalists, or other staff. Please maintain a copy of this notice in your records. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have questions regarding this communication, please contact your local representative or Customer Care at 1-877-211-1850, option 1 (Monday Friday 8:00 a.m. to 5:00 p.m. CST).

    Distribution

    US Nationwide distribution.

    Quantity

    3,258 units