Z-2638-2024Class II

L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539

Name: Z-2638-2024 L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
Creator: Argon Medical Devices, Inc
Published: 2024-06-14
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2024-06-14 / Open, Classified / root cause: manufacturing process

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 on 2024-06-14. FDA classified it as Class II and gives the reason as "Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2638-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-14
Posted: 2024-08-16
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
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 6/14/24,"URGENT PRODUCT RECALL NOTICE"s were emailed to Physicians, Clinicians, or Hospital Administrators describing the product, problem and the following actions to be taken. The customers were instructed to do the following: 1) Immediately discontinue use of the recalled device. 2) Segregate and quarantine the product subject to recall. 3) Return all affected devices to firm at Argon s expense, using RGA# 28348 to the following mailing address: RGA# 28348, Argon Medical Devices, Inc.,1445 Flat Creek Road Athens, TX 75751 USA, Attn: Arbee Cummings. 4) The recall notice should be shared with anyone who needs to be aware within your organization or to any organization where the potentially affected products have been transferred or further distributed. 5) Complete and return the response form via email to [email protected] If you need assistance in returning the units, please contact [email protected]. If you have any questions about this letter, please contact [email protected] or [email protected].
Quantity in commerce: 155
Distribution: US distribution to the states of: TX, WA, CA, IL
Product codes and lots: UDI-DI: 20886333209938, 00886333209934. Lot: 11563923. Expiration: 2027-03-11

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2638-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2638-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-21	2024-08-15

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)