Medline General Surgery Tray kits recallZ-0992-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Dec 31, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
FDA root cause category: Process design
What the company is doing
A MEDICAL DEVICE RECALL notification letter dated 12/31/24 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-24-278-FGX1 Recall Code: RECALL CODE 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
Recall details
- Recall number
- Z-0992-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 31, 2024
- Posted by the FDA
- Jan 29, 2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 58 kits
- Product code
- LRP
- Distribution
- US Nationwide.
Product description
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
Code information (models, lots, serial numbers)
1) ART600 UDI-DI: 10653160312727 (each), 00653160312720 (case), Lot Number 2024110190; 2) ART690 UDI-DI: 10653160318019 (each), 00653160318012 (case), Lot Number 2024092490
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Centurion ART690Centurion Medical Products Corporation · General Surgery Tray4 recalls0 reports
- Centurion ART600Centurion Medical Products Corporation · Cardiac catheterization kit2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96093).
- Z-0991-2025 · Open, ClassifiedMedline 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…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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