Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ...
FDA Recall #Z-0991-2025 — Class I — December 31, 2024
Product Description
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
Reason for Recall
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Recalling Firm
MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
942 kits
Distribution
US Nationwide.
Code Information
1) ART1185B UDI-DI: 10653160379225(each), 00653160379228(case), Lot Number: 2024102590; 2) ART255 UDI-DI: 10653160367598(each), 00653160367591(case), Lot Number: 2024082690; 3) ART255 UDI-DI: 10653160367598(each), 00653160367591(case), Lot Number: 2024101590; 4) ART350 UDI-DI: 10653160362050(each), 00653160362053(case), Lot Number: 2024093090; 5) ART355 UDI-DI: 10653160361817(each), 00653160361810(case), Lot Number: 2024081290; 6) ART355 UDI-DI: 10653160361817(each), 00653160361810(case), Lot Number: 2024112590; 7) ART475 UDI-DI: 10653160367659(each), 00653160367652(case), Lot Number: 2024100790; 8) ART475 UDI-DI: 10653160367659(each), 00653160367652(case), Lot Number: 2024073090; 9) ART475 UDI-DI: 10653160367659(each), 00653160367652(case), Lot Number: 2024081590; 10) ART475 UDI-DI: 10653160367659(each), 00653160367652(case), Lot Number: 2024090990; 11) ART535A UDI-DI: 10653160367604(each), 00653160367607(case), Lot Number: 2024100890; 12) ART535A UDI-DI: 10653160367604(each), 00653160367607(case), Lot Number: 2024080190; 13) ART545A UDI-DI: 10653160375135(each), 00653160375138(case), Lot Number: 2024102890; 14) ART775C UDI-DI: 10653160366102(each), 00653160366105(case), Lot Number: 2024083090; 15) ART840 UDI-DI: 10653160366966(each), 00653160366969(case), Lot Number: 2024082390; 16) ART840 UDI-DI: 10653160366966(each), 00653160366969(case), Lot Number: 2024093090; 17) ART890B UDI-DI: 10653160360834(each), 00653160360837(case), Lot Number: 2024100990;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated