Home / Recalls / Argon Medical Devices, Inc / Z-0295-2020

Z-0295-2020 Class II Terminated

Recalled by Argon Medical Devices, Inc — Athens, TX

Recall Details

Product Type
Devices
Report Date
November 13, 2019
Initiation Date
October 16, 2018
Termination Date
June 15, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Total number in recall for all products in dist: 49,130 units

Product Description

Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

Reason for Recall

The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

Distribution Pattern

Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.

Code Information

Lot numbers 11228251 and 11229805

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-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)
  • Z-1074-2021 Class II — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1 (December 10, 2020)