Recall Z-2803-2026

Argon Medical Devices, Inc · initiated June 15, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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

Codes / lots: 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)

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.

FDA-determined cause: Device Design

Action taken

On 6/15/2026, recall notices were emailed to customers who were asked to do the following: 1) Provide this recall notice to all people who need to be aware within your organization or to any organization where the potentially affected product has been transferred. 2) Segregate, quarantine, and return affected devices to recalling firm. 3) Complete and return the response form via email Arbee.cummings@argonmedical.com For additional information on this letter, please email Scott.Bishop@argonmedical.com

Details

Recall number
Z-2803-2026
Initiated
June 15, 2026
Posted by FDA
July 24, 2026
Product code
LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Quantity
6928
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
Recalling firm
Argon Medical Devices, Inc, Athens, TX

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2804-2026 Class IIL-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620Catheters, indicated for short/long-term peripheral access to central venous system for the administration… 06/15/2026Open, Classified