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Class IOngoingZ-0992-2025

MEDLINE INDUSTRIES, LP - Northfield recalls Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY

MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesReported Feb 5, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

UDI
10653160312727 (each), 00653160312720 (case)
Lot #
2024110190; 2) ART690
UDI
10653160318019 (each), 00653160318012 (case)
Lot #
2024092490

What the firm 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 recalls@medline.com.

DistributionShow details

US Nationwide.

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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