FDA Device recall Z-1886-2025
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack
- FDA Device
- Class II
- ongoing
- Published 2025-06-11
On 2025-06-11 the FDA classified a Class II recall of Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack by Mozarc Medical Us, citing potential breach of sterile barrier packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1886-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-23 |
| Published | 2025-06-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Mozarc Medical Us |
| Distribution | US |
Product
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Reason
Potential breach of sterile barrier packaging.
Identifiers
| code_info | Model No.8888128459P, 8888119369P, 8888133509P, 8888123409P; UDI: 20884521157870, 20884521157733, 20884521157948, 20884…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1886-2025%22
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