Home / Recalls / Argon Medical Devices, Inc / Z-1792-2020

Z-1792-2020 Class I Terminated

Recalled by Argon Medical Devices, Inc — Athens, TX

Recall Details

Product Type
Devices
Report Date
May 13, 2020
Initiation Date
December 4, 2019
Termination Date
April 1, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1190 units

Product Description

0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO

Reason for Recall

The stiffness of the soft end of the guidewire caused tissue perforation.

Distribution Pattern

No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England

Code Information

Guidewire Model 114135150; LOT numbers: 11248718, 11251204, 11260495. 11268741, 11242667, 11241250 and 11239540

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  • 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-1074-2021 Class II — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1 (December 10, 2020)
  • Z-1072-2021 Class II — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/ (December 10, 2020)
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