Argon Medical Devices, Inc: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Recall Summary Argon Medical Devices is recalling several models of L-Cath PICC catheters used for long-term central venous access because the hub connection may leak or crack. This defect could prevent the catheter from being flushed or used properly, interrupt treatment, cause blood loss, tissue irritation, or lead to bloodstream infections. The affected catheters were distributed across most U.S. states as well as Canada, Malaysia, and Saudi Arabia.
- Recalling firm
- Argon Medical Devices, Inc
- Product
- 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
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-15
- Status
- Open, Classified
- Areas affected
- AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, MD, ...
- 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
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ba4cfdb0-3e22-437e-b558-fc3a0ce69752