FDA recall Z-2804-2026

Argon Medical Devices, Inc · Class II · device

Product

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.

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

Key facts

Status
Ongoing
Initiation date
2026-06-15
Report date
2026-08-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Athens, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2804-2026