Recall Z-2804-2026— Argon Medical Devices, Inc

Class II · Ongoing

Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2026-06-15. It names one FDA 510(k) clearance: K230669. Product: L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620. Reason: 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..

Recalling firm
Argon Medical Devices, Inc
Classification
Class II
Status
Ongoing
Initiated
2026-06-15
Firm location
Athens, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.