FDAFDA · Food and drugs·Recall number Z-2705-2026
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Published July 22, 2026 · Recall initiated: June 1, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Argon Medical Devices, Inc
- Distributor
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- Lot
- REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027);
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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