Mozarc Medical US LLC recalls MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Comp…

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

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

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 uscustomercare@mozarcmedical.com 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).

• FDA enforcement recordOfficial FDA database entry for Z-0421-2026
• FDA 510(k) clearance · K192302The device's official FDA premarket clearance record
• FDA device classification · NIEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5540The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Mozarc Medical US LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.