L-Cath PICC S/L recallZ-2803-2026 · Argon Medical Devices, Inc · initiated Jun 15, 2026

Why it was recalled

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 root cause category: Device Design

What the company is doing

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 [email protected] For additional information on this letter, please email [email protected]

Recall details

Recall number

Z-2803-2026

Status

Open, Classified

Initiated by the company

Jun 15, 2026

Posted by the FDA

Jul 24, 2026

Recalling firm

Argon Medical Devices, Inc

Quantity

6928

Product code

LJS

FDA submissions

K230669

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

Product description

L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1.00mm x 60cm, REF: 384463

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

• L-Cath™ S/L PICC S/L 26GA (1.9F) x 30cm

  Argon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
  2 recalls245 reports
• L-CathTM PICC S/L 28 GA (1.2F) x 25cm

  Argon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
  1 recall1 death115 reports
• L-Cath PICC S/L 20 GA (3F) 1.0mm x 60cm

  Argon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
  1 recall28 reports
• L-Cath™ PICC S/L 18GA (3.5F) 1.15mm x 60cm

  Argon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
  1 recall2 reports

Product lines

• L-Cath PICC S/LArgon Medical Devices, Inc. · 2 models · 30 reports · 1 recall

Other products in the same recall event

The FDA groups related products into one recall event (event 99333).

• Z-2804-2026 · Open, Classified
  L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620