Recall Z-0425-2026 ยท NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Mozarc Medical US LLC
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
| Date | Nov 4, 2025 (initiated Oct 17, 2025) |
| Status | Open, Classified |
| Reason | A potential issue with the seal integrity of header bag packaging. |
| Root cause | Under Investigation by firm |
| 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 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 organiz |
| Quantity | 3,258 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192302 | Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Covidien, LLC, Jan 17, 2020 |