Class 2 Device Recall Arterial Line Kit

• Date Initiated by Firm: January 24, 2022
• Create Date: February 04, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0563-2022
• Recall Event ID: 89439
• 510(K)Number: K780871
• Product Classification: Gauze/sponge, internal, x-ray detectable - Product Code GDY
• Product: 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
• Code Information: 1. Model: 400115A and Serial # 11377499, Expire Date: 10/27/2022 2. Model: 498100 and Serial # 11378381, Expire Date: 4/15/2026
• Recalling Firm/ Manufacturer: Argon Medical Devices, Inc; 1445 Flat Creek Rd; Athens TX 75751-5002
• For Additional Information Contact: Rebecca Ellis; 469-731-1410
• Manufacturer Reason for Recall: Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.
• FDA Determined Cause: Mixed-up of materials/components
• Action: Urgent Product Recall Notice was send out to the affected customers on 01/24/2022 via registered mail: The notification letter to each customer identify the specific lots and quantities that were shipped to that customer, and requesting to take the following action by customer. 1. Complete and return product inventory sheet quickly as possible 2. Notify/share the notification with anyone who needs to be aware within your organization or to any organization where the potentially affected products have been transferred. 3. Return all affected product to Argon Athens facility using RGA# provided in the notification. If you have any questions about the recall letter or about the recall action it describes in the notification, please contact Brian.Rogers@argonmedical.com. You may also contact Arbee.Cummings@argonmedical.com or Andrea.Wieczor@argonmedical.com
• Quantity in Commerce: 600 ea
• Distribution: US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GDY