Argon Medical Devices, Inc: L-CATH PICC Catheters Recalled for Incorrect Catheter Length in Package

Agency Publication Date: August 16, 2024

Summary

Approximately 155 L-CATH PICC S/L Peripherally Inserted Central Catheters are being recalled because the packaging is labeled as containing a 30cm catheter, but the package actually contains a longer 50cm catheter. This mislabeling can cause significant delays during medical procedures while clinical staff work to find the correct replacement equipment. These catheters were distributed to Texas, Washington, California, and Illinois and have an expiration date of March 11, 2027.

Risk

The presence of a catheter that is 20cm longer than what is indicated on the label could lead to confusion and procedural delays during placement. Such delays in establishing venous access can negatively impact patient care in time-sensitive medical situations.

What You Should Do

Check your medical inventory for L-CATH PICC S/L Peripherally Inserted Central Catheters, 26Ga (1.9F) 0.60mm x 30cm, with Reference Number 384539.
Verify the lot number and UDI on the packaging; the affected units are marked with Lot Number 11563923, UDI-DI 20886333209938 or 00886333209934, and an expiration date of 2027-03-11.
Contact your healthcare provider or the manufacturer, Argon Medical Devices, Inc., at 1445 Flat Creek Rd, Athens, Texas, for instructions on how to return or replace the mislabeled products.
If you have further questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer initiated recall due to labeling error.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

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

Model / REF:

384539

UPC Codes:

20886333209938

00886333209934

Lot Numbers:

11563923 (Exp: 2027-03-11)

Date Ranges: Expiration: 2027-03-11

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94951

Status: Active

Manufacturer: Argon Medical Devices, Inc

Manufactured In: United States

Units Affected: 155

Distributed To: Texas, Washington, California, Illinois

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medical inventory for L-CATH PICC S/L Peripherally Inserted Central Catheters, 26Ga (1.9F) 0.60mm x 30cm, with Reference Number 384539.

Verify the lot number and UDI on the packaging; the affected units are marked with Lot Number 11563923, UDI-DI 20886333209938 or 00886333209934, and an expiration date of 2027-03-11.

Contact your healthcare provider or the manufacturer, Argon Medical Devices, Inc., at 1445 Flat Creek Rd, Athens, Texas, for instructions on how to return or replace the mislabeled products.

If you have further questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.