Z-2803-2026Class II

L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F)...

Name: Z-2803-2026 L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F)...
Creator: Argon Medical Devices, Inc
Published: 2026-06-15
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2026-06-15 / Open, Classified / root cause: design

FDA source

Argon Medical Devices, Inc began a recall of 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... on 2026-06-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2803-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-15
Posted: 2026-07-24
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
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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 [email protected] For additional information on this letter, please email [email protected]
Quantity in commerce: 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
Product codes and 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2803-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2803-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-24
Z-2804-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-24

Product code LJS

K230669Class IIL-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline CathetersArgon Medical Devices / cleared 2023-11-30

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)