MEDLINE INDUSTRIES, LP - Northfield recalls Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item…

Recall date

December 31, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0991-2025

FDA classification

Class I

Brand / firm

MEDLINE INDUSTRIES, LP - Northfield

Sold / distributed

US Nationwide.

Why it was recalled

The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE BUNDLE, Item Number ART355; 5) ARTERIAL LINE BUNDLE, Item Number ART355 ; 6) ARTERIAL LINE INSERTION TRAY, Item Number ART475; 7) ARTERIAL LINE BUNDLE - OR, Item Number ART535A; 8) ARTERIAL LINE TRAY, Item Number ART545A; 9) ARTERIAL LINE INSERTION KIT, Item Number ART775C; 10) ARTERIAL LINE TRAY, Item Number ART840; 11) ARTERIAL LINE KIT, Item Number ART890B