Device product
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
Z-0992-2025
Product summary
- Event
- Event 96093
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 58 kits
- Official record key
device-enforcement:Z-0992-2025
Official wording
Reason: The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Code information: 1) ART600 UDI-DI: 10653160312727 (each), 00653160312720 (case), Lot Number 2024110190; 2) ART690 UDI-DI: 10653160318019 (each), 00653160318012 (case), Lot Number 2024092490
Distribution pattern: US Nationwide.
Derived failure modes
-
Unknown
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.