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

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.

Details from the source

Reason for recall: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. Distribution: Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago. Quantity: 200 Lot/code info: REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027);

UPC codes

20886333214499, 00886333214495, 20886333214635, 00886333214631

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.