Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
This recall is currently active, issued January 29, 2025. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- December 31, 2024
- Posted
- January 29, 2025
- Recall Number
- Z-0992-2025
- Quantity
- 58 kits
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Distribution
US Nationwide.
Lot / Code Info
1) ART600 UDI-DI: 10653160312727 (each), 00653160312720 (case), Lot Number 2024110190; 2) ART690 UDI-DI: 10653160318019 (each), 00653160318012 (case), Lot Number 2024092490
Root Cause
Process design
Action Taken
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 recalls@medline.com.