Class II — Mozarc Medical US LLC
| Recalling firm | Mozarc Medical US LLC |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | A potential issue with the seal integrity of header bag packaging. |
| Product | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm; |
| Quantity | 3,258 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2025-10-17 |
| Classified | 2025-11-04 |
| Recall number | Z-0424-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Mozarc Medical US LLC (Z-0424-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97848/
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