Z-0992-2025 Class I Ongoing
FDA device recall Z-0992-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on December 31, 2024 and is designated Class I. Reason for recall: The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub. The recall status is ongoing. Affected quantity: 58 kits.
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2025
- Initiation Date
- December 31, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58 kits
Product Description
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
Reason for Recall
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Distribution Pattern
US Nationwide.
Code Information
1) ART600 UDI-DI: 10653160312727 (each), 00653160312720 (case), Lot Number 2024110190; 2) ART690 UDI-DI: 10653160318019 (each), 00653160318012 (case), Lot Number 2024092490