FDA recall Z-0992-2025

MEDLINE INDUSTRIES, LP - Northfield · Class I · device

Product

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

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2024-12-31
Report date
2025-02-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0992-2025