Home / Recalls / Argon Medical Devices, Inc / Z-2806-2020

Z-2806-2020 Class II Terminated

Recalled by Argon Medical Devices, Inc — Athens, TX

Recall Details

Product Type
Devices
Report Date
August 26, 2020
Initiation Date
June 19, 2020
Termination Date
April 12, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1000 units

Product Description

ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or artery, allowing various catheters to be passed through for local or central diagnostic or therapeutic interventions. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

Reason for Recall

Sterile introducer sheath set manufactured under one lot with different expiration dates.

Distribution Pattern

US Nationwide distribution including in the state of MS.

Code Information

LOT 11295042

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  • 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-1072-2021 Class II — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/ (December 10, 2020)
  • Z-1075-2021 Class II — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1 (December 10, 2020)
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