Recalls / —

—#211993

Product

Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690

FDA product code

LRP — Tray, Surgical

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected 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

Why it was recalled

The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm

MEDLINE INDUSTRIES, LP Northfield

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

US Nationwide.

Timeline

Recall initiated

2024-12-31

Posted by FDA

2025-01-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #211993. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.