FDAFDA · Food and drugs·Recall number Z-1886-2025
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Published June 11, 2025 · Recall initiated: April 23, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential breach of sterile barrier packaging.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mozarc Medical US LLC
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
- Lot
- Model No.8888128459P, 8888119369P, 8888133509P, 8888123409P; UDI: 20884521157870, 20884521157733, 20884521157948, 20884521157801; Lot/Serial No. 2133600044, 2201700104, 2203300067, 2228000065, 2228000067, 2228000077, 2234800091, 2234800133, 2234800161, 2301100103, 2302500152, 2302500153, 2302500156, 2302500158, 2305300130, 2318500118, 2318500120, 2318500143, 2330300100, 2330300102, 2332700278, 2332700279, 2335200415, 2335200416, 2402400082, 2402400083, 2402400084, 2405800231, 2418000151, 2424200129, 2426300194, 2427700220.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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