SeriousFDAOngoing
Can cause serious harm or death.
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Check the device or its packaging for
REF/UDI-DI Box:Unit/Lot(Expiration): 008416A/20886333217636:00886333217632/11656898(7/19/2027); 008566A/20886333217643:00886333217649/11654475(12/31/2026), 11654478(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-2704-2026 · retrieved 10 July 2026
Read the official notice