FDA Enforcement
Class II
Ongoing
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
Recall: Z-0421-2026
·
Reported November 12, 2025
Enforcement
- Recall Number
- Z-0421-2026
- Event ID
- 97848
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Mozarc Medical US LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- November 12, 2025
- Initiation Date
- October 17, 2025
- Classification Date
- November 4, 2025
- Address
- 15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States
Description
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
Reason
A potential issue with the seal integrity of header bag packaging.
Code Info
REF Number: 8888101001HP; UDI-DI: (Individual unit) 10884521127890, (Carton) 20884521127897; Lot number: 2430500021
Distribution
US Nationwide distribution.
Quantity
3,258 units