FDA Enforcement
Class II
Ongoing
MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Recall: Z-1889-2025
·
Reported June 11, 2025
Enforcement
- Recall Number
- Z-1889-2025
- Event ID
- 96809
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Mozarc Medical US LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 11, 2025
- Initiation Date
- April 23, 2025
- Classification Date
- May 30, 2025
- Address
- 15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States
Description
MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Reason
Potential breach of sterile barrier packaging.
Code Info
Model No.8888133502; UDI: A8845210569201; Lot/Serial No. 241760200.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
Quantity
95,938 units