FDA Device recall Z-0992-2025
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600
- FDA Device
- Class I
- ongoing
- Published 2025-02-05
On 2025-02-05 the FDA classified a Class I recall of Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600 by Medline Industries Northfield, citing the catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0992-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-12-31 |
| Published | 2025-02-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
Reason
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Identifiers
| code_info | 1) ART600 UDI-DI: 10653160312727 (each), 00653160312720 (case), Lot Number 2024110190; 2) ART690 UDI-DI: 10653160318019…1) ART600 UDI-DI: 10653160312727 (each), 00653160312720 (case), Lot Number 2024110190; 2) ART690 UDI-DI: 10653160318019 (each), 00653160318012 (case), Lot Number 2024092490 |
|---|
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-0992-2025%22
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