MEDLINE INDUSTRIES, LP - Northfield recalls Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSE
Recalled Product
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
Hazard / Issue
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: 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;