Home / Recalls / Argon Medical Devices, Inc / Z-2252-2017

Z-2252-2017 Class II Terminated

Recalled by Argon Medical Devices, Inc — Athens, TX

Recall Details

Product Type
Devices
Report Date
June 14, 2017
Initiation Date
May 11, 2017
Termination Date
January 25, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7140 pieces

Product Description

Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.

Reason for Recall

Argon Medical has received a complaint from one of their distributors of a potential packaging defect. The product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch.

Distribution Pattern

Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, Netherlands

Code Information

11161099 11161729 11160990 11160912

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-2501-2021 Class II — Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepa (July 8, 2021)
  • Z-1076-2021 Class II — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 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-1074-2021 Class II — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1 (December 10, 2020)