FDA Medical devices recall ·
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0992-2025
- 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
- 58 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
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) ART600 UDI-DI: 10653160312727 (each), 00653160312720 (case), Lot Number 2024110190; 2) ART690 UDI-DI: 10653160318019 (each), 00653160318012 (case), Lot Number 2024092490
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-0992-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.