Midline Catheter Recalled Over Risk of Leaking or Cracking at Hub
Argon Medical Devices is recalling its L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm (REF 384620) because the hub may leak or crack, potentially causing therapy interruption, blood loss, or bloodstream infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported injuries in the notice; the potential for hub leak/crack creating risk of bloodstream infection and blood loss fits the 'risk-of-harm products where injury has not yet been reported' High criterion.
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
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- REF/UDI-DI/Lot(Expiration): 384620/00886333210008/11490543(7/28/2026)
Distribution
Part of a larger recall action
This product is one of 2 recalled by Argon Medical Devices, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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