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

Medical DevicesSource: FDA (device) · Date: 2026-07-22

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Argon Medical Devices, Inc
Product
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Reason / 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.
Classification
Class I
Status
Ongoing
Distribution / sold at
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Recall initiated
2026-06-01
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)
Product quantity
950
Voluntary mandated
Voluntary: Firm initiated
City
Athens
State
TX
Country
United States
Event id
99069
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