FDA Medical devices recall ·
Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0991-2025
- Date
- (initiated December 31, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 942 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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;
Distribution
US Nationwide.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0991-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.