SeriousFDAOngoing
Can cause serious harm or death.
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Check the device or its packaging for
REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027);
- Why
- Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Distributed
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- Company
- Argon Medical Devices, Inc
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2705-2026 · retrieved 10 July 2026
Read the official notice