Home / Recalls / Argon Medical Devices, Inc / Z-2501-2021

Z-2501-2021 Class II Ongoing

Recalled by Argon Medical Devices, Inc — Athens, TX

Recall Details

Product Type
Devices
Report Date
September 29, 2021
Initiation Date
July 8, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20 units

Product Description

Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.

Reason for Recall

As a result of design changes, sheaths have exhibited cracking/breaking at the tips.

Distribution Pattern

U.S. Nationwide distribution in the state of WA. O.U.S.: N/A

Code Information

Item Numbers: TPS005 (Stylet); TPS006 (Needle); UDI Code: 00886333225552 Lot Number: 11369609

Other recalls by Argon Medical Devices, Inc

  • Z-0589-2026 Class II — Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 0088633321715 (September 12, 2025)
  • Z-3192-2024 Class II — BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, (July 2, 2024)
  • Z-2638-2024 Class II — L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30c (June 14, 2024)
  • Z-2239-2023 Class II — Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter (June 8, 2023)
  • Z-0563-2022 Class II — 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6" (January 24, 2022)
  • Z-0354-2022 Class II — SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BI (October 4, 2021)
  • Z-1075-2021 Class II — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1 (December 10, 2020)
  • Z-1073-2021 Class II — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/ (December 10, 2020)
  • Z-1077-2021 Class II — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1 (December 10, 2020)
  • Z-1072-2021 Class II — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/ (December 10, 2020)