FDA Enforcement
Class II
Ongoing
Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Recall: Z-1888-2025
·
Reported June 11, 2025
Enforcement
- Recall Number
- Z-1888-2025
- 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
Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Reason
Potential breach of sterile barrier packaging.
Code Info
Model No.8888123405P, 8888123411P, 8888128455P, 8888128461P, 8888119365P, 8888119371P, 8888133505P; UDI: 20884521157788, 20884521157825, 20884521157856, 20884521157894, 20884521157719, 10884521157750, 20884521157924; Lot/Serial No. 2204000102, 2228000068, 2228000070, 2234800148, 2234800159, 2234800160, 2302500128, 2305300136, 2315600104, 2315600113, 2315600119, 2315600122, 2318500135, 2318500136, 2318500140, 2320000255, 2332700275, 2335200414, 2412000238, 2412000239, 2414300228, 2414300233, 2418000150, 2426300169.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
Quantity
95,938 units