Mozarc Medical US LLC
Mansfield, MA, US
MOZARC MEDICAL US LLC appears in FDA device records in Mansfield, MA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 12 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Mozarc Medical US LLC in 2026.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253469 | Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) | FIE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3030574705 | 3030574705 | MOZARC MEDICAL US LLC | 15 Hampshire Street, Mansfield, MA 02048 US | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNZAccessories, A-V Shunt
- KGZAccessories, Catheter
- FIQCannula, A-V Shunt
- LITCatheter, Angioplasty, Peripheral, Transluminal
- KRACatheter, Continuous Flush
- MSDCatheter, Hemodialysis, Implanted
- NYUCatheter, Hemodialysis, Implanted, Coated
- MPBCatheter, Hemodialysis, Non-Implanted
- NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- FKOCatheter, Peritoneal Dialysis, Single Use
- FJSCatheter, Peritoneal, Long-Term Indwelling
- LFJCatheter, Subclavian
- DREDilator, Vessel, For Percutaneous Catheterization
- DYBIntroducer, Catheter
- NFKKit, Repair, Catheter, Hemodialysis
- FIENeedle, Fistula
- DQXWire, Guide, Catheter
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2319-2026 | 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 (8888222420), 12 FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221420), 12 FR x 24cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222424), 12 FR x 24cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221424), 12 FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221430), 12.5 FR x 13 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233413), 12.5 FR x 16 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233416), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233420), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231420), 12.5 FR x 24 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233424), 12.5 FR x 24 cm, Acute Triple Lumen Catheter with Straight Extensions PASS Tray (8888231424), 12.5 FR x 30 cm, Triple Lumen Catheter with Straight Extensions PASS Tray (8888231430), 12.5FR x 13cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231413), 12.5FR x 16cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231416), 13.5 FR x 16 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213416), 13.5 Fr x 16cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211416), 13.5 FR x 20 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213420), 13.5 Fr x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211420), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212413), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211413), 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212416), 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212420), 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211424); for acute hemodialysis, aphaeresis, and infusion. | The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays. | Class II | Open, Classified | |
| Z-0426-2026 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm; | A potential issue with the seal integrity of header bag packaging. | Class II | Open, Classified | |
| Z-0425-2026 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm; | A potential issue with the seal integrity of header bag packaging. | Class II | Open, Classified | |
| Z-0424-2026 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm; | A potential issue with the seal integrity of header bag packaging. | Class II | Open, Classified | |
| Z-0423-2026 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm; | A potential issue with the seal integrity of header bag packaging. | Class II | Open, Classified | |
| Z-0422-2026 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm; | A potential issue with the seal integrity of header bag packaging. | Class II | Open, Classified | |
| Z-0421-2026 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm; | A potential issue with the seal integrity of header bag packaging. | Class II | Open, Classified | |
| Z-1889-2025 | MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | Potential breach of sterile barrier packaging. | Class II | Open, Classified | |
| Z-1888-2025 | Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | Potential breach of sterile barrier packaging. | Class II | Open, Classified | |
| Z-1887-2025 | Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | Potential breach of sterile barrier packaging. | Class II | Open, Classified | |
| Z-1886-2025 | Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | Potential breach of sterile barrier packaging. | Class II | Open, Classified | |
| Z-1885-2025 | Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | Potential breach of sterile barrier packaging. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain