Class II U.S. Food and Drug Administration

Argon Medical Devices, Inc L-Cath PICC S/L Peripherally Inserted Central Catheter recall: Catheters, indicated for short/long-term peripheral access to central venous

Recall published 3 months ago

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.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2803-2026
Published
August 5, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Argon Medical Devices, Inc
Product type
Medical devices
Units affected
6928
Distribution
Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, Nevada, New York, Oregon, Tennessee, Texas, Utah, Virginia, Washington
Made in
United States
Lot / code info
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)
UPC codes
00886333209934, 00886333209835, 00886333209910, 00886333209828

Products covered by this recall

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

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00886333209934
  • 00886333209835
  • 00886333209910
  • 00886333209828

Model or item number

On the rating label, the box or the instruction sheet.

  • 384539
  • 384464
  • 384516
  • 384463 — REF
  • UDI-DI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Argon Medical Devices, Inc — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Argon Medical Devices, Inc — 1445 Flat Creek Rd, Athens, TX, 75751-5002

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Argon Medical Devices, Inc medical devices recalled?

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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00886333209934, 00886333209835, 00886333209910; model number 384539, 384464, 384516. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Which states were affected?

The notice lists Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts and others.

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