Argon Medical Devices, Inc: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A

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: 950 Lot/code info: 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)

UPC codes

20886333217636, 00886333217632, 20886333217643, 00886333217649

Source

Official record: FDA (Device enforcement) ↗

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