Midline Catheter Recalled Over Risk of Leaking or Cracking at Hub

Plain-English summary

Argon Medical Devices, Inc. is recalling the L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF 384620 (lot 11490543, expiration 7/28/2026). The catheter is used for short- or long-term peripheral access to the central venous system to administer fluids, medications, and nutrients, and for blood sampling.

The recall was triggered because the catheter hub may leak or crack. According to the FDA notice, this could lead to catheter replacement, inability to flush or aspirate the catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, or bloodstream infection.

The affected product was distributed in the U.S. and internationally, with U.S. distribution to 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, and outside the U.S. to MYS, CAN, SAU. The FDA has classified this as a Class II recall.

The recall notice does not include specific consumer instructions. Healthcare providers and patients should verify whether they have the affected lot and contact Argon Medical Devices or their healthcare provider for guidance.

The recalled product

Product

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

Manufacturer

Argon Medical Devices, Inc

Category

Medical Device — Vascular Access Catheter

Hazard

• device-leak
• device-crack
• bloodstream-infection
• blood-loss

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Related recalls