Recall Z-2803-2026
- Recall number
- Z-2803-2026
- Event number
- 99333
- Firm
- Argon Medical Devices, Inc
- Firm FEI
- 1625425
- Product code
- LJS
- Status
- Open, Classified
- Initiated
- 2026-06-15
- Posted
- 2026-07-24
- Root cause
- Device Design
- 510(k) numbers
- K230669, K172899, K935380, K972555, K061986, K010349, K895543, K050931, K921755, K070615, K051194, K222232, K050889, K003839, K053501, K170934, K963215, K001874, K092347, K130507, K030400, K093309, K840846, K961336, K051991, K143238, K031718, K944685, K140345, K091466
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 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.