Z-2803-2026 Class II Ongoing
FDA device recall Z-2803-2026 was initiated by Argon Medical Devices, Inc on June 15, 2026 and is designated Class II. 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 th… The recall status is ongoing. Affected quantity: 6928.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2026
- Initiation Date
- June 15, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6928
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
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.
Distribution Pattern
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
Code Information
REF/UDI-DI/Lot(Expiration): 384539/00886333209934/11488167(7/14/2026), 11488168(7/17/2026), 11494535E(8/1/2026), 11507766(11/13/2026), 11550780(12/12/2026), 11551487(12/15/2026), 11551488(12/15/2026); 384464/00886333209835/11490593(7/28/2026), 11494886(8/28/2026)11501150(10/6/2026); 384516/00886333209910/11500410(8/14/2026), 11501856(8/14/2026), 11504222(9/9/2026), 11506952(9/9/2026), 11523868(9/18/2026), 11551789(9/18/2026), 11553909(11/13/2026), 11559226(11/20/2026); 384463/00886333209828/11490797(8/1/2026), 11490959(8/11/2026)