FDA DeviceClass INotable

FDA Recall: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A

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

950

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