Recall Z-2704-2026— Argon Medical Devices, Inc
Class I · Ongoing
Class I FDA medical device recall by Argon Medical Devices, Inc, initiated 2026-06-01. Product: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A. Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility..
- Recalling firm
- Argon Medical Devices, Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-06-01
- Firm location
- Athens, TX, United States
Product description
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.