Chrysalis Intelligence · Sponsors · Mozarc Medical Us, LLC

Mozarc Medical Us, LLC

Mansfield, MA, US · 1 510(k) clearances · 11 recalls

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Total clearances

1

2026-08-06 → 2026-08-06

Last 12 months

1

Product codes

1

Most recent

2026-08-06

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
FIE	—	—	—	1	2026-08-06

Safety

Recalls (11)

Class I (serious)

0

Risk of injury / death

Total recalls

11

Currently ongoing

11

Most recent

2025-10-17

Date	Severity	Status	Recall #	Product	Code	Reason
2025-10-17	Class II	Ongoing	Z-0426-2026	MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm…	—	A potential issue with the seal integrity of header bag packaging.
2025-10-17	Class II	Ongoing	Z-0425-2026	MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 …	—	A potential issue with the seal integrity of header bag packaging.
2025-10-17	Class II	Ongoing	Z-0424-2026	MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 …	—	A potential issue with the seal integrity of header bag packaging.
2025-10-17	Class II	Ongoing	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.
2025-10-17	Class II	Ongoing	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.
2025-10-17	Class II	Ongoing	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.
2025-04-23	Class II	Ongoing	Z-1889-2025	MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.	—	Potential breach of sterile barrier packaging.
2025-04-23	Class II	Ongoing	Z-1888-2025	Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.	—	Potential breach of sterile barrier packaging.
2025-04-23	Class II	Ongoing	Z-1887-2025	Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.	—	Potential breach of sterile barrier packaging.
2025-04-23	Class II	Ongoing	Z-1886-2025	Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.	—	Potential breach of sterile barrier packaging.
2025-04-23	Class II	Ongoing	Z-1885-2025	Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.	—	Potential breach of sterile barrier packaging.

Filings

All 510(k) clearances (1)

Date	K-number	Device	Code	Class	Specialty
2026-08-06	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	—	—