Z-1888-2025 Class II Ongoing
FDA device recall Z-1888-2025 was initiated by Mozarc Medical US LLC on Apr 23, 2025 and is designated Class II. Reason for recall: Potential breach of sterile barrier packaging. The recall status is ongoing. Affected quantity: 95,938 units.
Recall details
- Product Type
- Devices
- Report Date
- Jun 11, 2025
- Initiation Date
- Apr 23, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 95,938 units
Product description
Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Reason for recall
Potential breach of sterile barrier packaging.
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
Code information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1888-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026