Argon Medical Devices, Inc: Device Recall

Recall Details

Recall Number

Z-2638-2024

Classification

Class II

Product Type

Device

Recalling Firm

Argon Medical Devices, Inc

Status

Ongoing

Date Initiated

06/14/2024

Location

Athens, TX, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

155

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.

Product Description

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

Distribution Pattern

US distribution to the states of: TX, WA, CA, IL

Other Recalls by Argon Medical Devices, Inc

• Class II: Risk 09/12/2025
  Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied
• Class II: Risk 07/02/2024
  Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.

View all recalls by Argon Medical Devices, Inc →