FDA Device recall Z-0424-2026
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm
- FDA Device
- Class II
- ongoing
- Published 2025-11-12
On 2025-11-12 the FDA classified a Class II recall of MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm by Mozarc Medical Us, citing A potential issue with the seal integrity of header bag packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0424-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-17 |
| Published | 2025-11-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Mozarc Medical Us |
| Distribution | US |
Product
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Reason
A potential issue with the seal integrity of header bag packaging.
Identifiers
| code_info | REF Number: 8888102003HP; UDI-DI: (Individual unit) 10884521127999, (Carton) 20884521127996; Lot number: 2418000195; |
|---|
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-0424-2026%22
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