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Argon Medical Devices, Inc: One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular

Medical DevicesSource: FDA (device) · Date: 2026-07-22

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Argon Medical Devices, Inc
Product
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Reason / hazard
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Classification
Class I
Status
Ongoing
Distribution / sold at
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Recall initiated
2026-06-01
Code info
REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027);
Product quantity
200
Voluntary mandated
Voluntary: Firm initiated
City
Athens
State
TX
Country
United States
Event id
99069
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