Z-1887-2025 Class II Ongoing
FDA device recall Z-1887-2025 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 SI 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.8888133508P, 8888123408P, 8888119368P, 8888128458P; UDI: 20884521157931, 20884521157795, 20884521157726, 20884521157863; Serial No. 2234800132, 2302500141, 2302500148, 2305300142, 2305300144, 2305300177, 2313800083, 2324100168, 2324100310, 2324100311, 2405800229, 2426300218, 2426700122, 2427700199.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1887-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026