Home / Recalls / Argon Medical Devices, Inc / Z-2109-2020

Z-2109-2020 Class II Terminated

Recalled by Argon Medical Devices, Inc — Athens, TX

Recall Details

Product Type
Devices
Report Date
June 3, 2020
Initiation Date
April 26, 2020
Termination Date
December 16, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15,795 units

Product Description

Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for catheter placement in non-vascular procedures.

Reason for Recall

Tungsten coils of the guidewire included in the introducer kit were detaching.

Distribution Pattern

International distribution to the countries of China, Taiwan.

Code Information

REF /LOT: 651506300/ 11267865, 11271397, 11277305, 11287825, 11293349, 11288772, 11290387, 11263199, 11262264, 11258778, 11254942, 11253443 REF/ LOT: 655506300 / 11268009, 11284776, 11266592, 11285976, 11287826, 11280359, 11260512, 11252843, 11248583, 11277295

Other recalls by Argon Medical Devices, Inc

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  • 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-1075-2021 Class II — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 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)