Class 2 Device Recall LCath Midline Catheter

• Date Initiated by Firm: June 15, 2026
• Date Posted: July 24, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2804-2026
• Recall Event ID: 99333
• 510(K)Number: K230669
• Product Classification: Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
• Product: L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
• Code Information: REF/UDI-DI/Lot(Expiration): 384620/00886333210008/11490543(7/28/2026)
• FEI Number: 1625425
• Recalling Firm/ Manufacturer: Argon Medical Devices, Inc; 1445 Flat Creek Rd; Athens TX 75751-5002
• For Additional Information Contact: Scott Bishop; 469-430-0546
• Manufacturer Reason for Recall: Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
• FDA Determined Cause: Device Design
• Action: On 6/15/2026, recall notices were emailed to customers who were asked to do the following: 1) Provide this recall notice to all people who need to be aware within your organization or to any organization where the potentially affected product has been transferred. 2) Segregate, quarantine, and return affected devices to recalling firm. 3) Complete and return the response form via email Arbee.cummings@argonmedical.com For additional information on this letter, please email Scott.Bishop@argonmedical.com
• Quantity in Commerce: 20
• Distribution: US: AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OR, TN, TX, UT, VA, WA. OUS: MYS, CAN, SAU
• 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 = LJS