Recall Z-2638-2024— Argon Medical Devices, Inc

Name: FDA recall Z-2638-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-14

Class II · Ongoing

Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2024-06-14. It names one FDA 510(k) clearance: K230669. Product: L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539. Reason: 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..

Recalling firm: Argon Medical Devices, Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-06-14
Firm location: Athens, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K230669 — L-Cath Single and Dual Lumen Catheters, L-Cath Midline CathetersArgon Medical Devices·cleared 2023-11-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.