MEDLINE INDUSTRIES, LP - Northfield medical device recall: Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96093
- Recall initiated
- Dec 31, 2024
- Classified by FDA
- Jan 29, 2025
- Posted in Enforcement Report
- Feb 5, 2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Firm location
- Northfield, IL, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 2
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Dec 31, 2024. FDA classified it 29 days later, on Jan 29, 2025. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: US Nationwide. MEDLINE INDUSTRIES, LP - Northfield has 257 recalls in our records.
Recalled products (2)
Z-0991-2025 Class I Ongoing
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
Codes / lots: 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:…
Quantity: 942 kits
Z-0992-2025 Class I Ongoing
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
Codes / lots: 1) ART600 UDI-DI: 10653160312727 (each), 00653160312720 (case), Lot Number 2024110190; 2) ART690 UDI-DI: 10653160318019 (each), 00653160318012 (case), Lot Number 2024092490
Quantity: 58 kits
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96093
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.