FDA DeviceClass INotable

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

Date: 2026-07-22
Brand: Argon Medical Devices, Inc
Category: Medical Device
FDA Class: Class I

Description

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

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.

Remedy

200

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