medical HIGH RISK Updated 2026-07-22

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

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Recalled Product

One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular

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Hazard / Issue

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027);

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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