Recall Z-2319-2026 ยท MPB Catheter, Hemodialysis, Non-Implanted
Mozarc Medical US LLC
Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222416), 12 FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221416), 12 FR x 20cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (
| Date | Jun 5, 2026 (initiated Apr 29, 2026) |
| Status | Open, Classified |
| Reason | The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays. |
| Root cause | Under Investigation by firm |
| Action | On April 29, 2026 URGENT: MEDICAL DEVICE FIELD NOTICE letters were sent to customers. Actions to be taken: 1. If the Clinician notes that the Tegaderm dressing is not in the tray before or during Mahurkar" Elite PASS Tray use, an alternate sterile catheter dressing may be used as is customary in hospital settings where sterile dressings are routinely available as the standard clinical practice for dialysis catheters. 2. 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. |
| Quantity | 25627 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120674 | MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER Covidien, Apr 4, 2012 |