FDA-Device2026-07-22Class IPACKAGING DEFECT
Argon Medical Devices pacing electrode trays recalled for sterility failure in lidocaine ampules
OTHERNationwide distribution
Argon Medical pacing electrode trays recalled for sterility risk
Argon Medical Devices is recalling certain transvenous pacing electrode trays (model 008416A and 008566A) because they contain lidocaine ampules that did not meet sterility standards. The affected kits were distributed nationwide and internationally. No injuries have been reported.
- Contact Argon Medical Devices if you have one of the affected kits (REF 008416A or 008566A)
- Do not use the kits until you receive instructions from the manufacturer
- Report any issues to the FDA MedWatch program
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.
Sold states
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Affected count
950
Manufactured in
1445 Flat Creek Rd, Athens, TX, United States
Products
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2704-2026More Argon Medical Devices, Inc recalls
- FDA-Device2026-07-22Argon Medical Devices General Biopsy Tray recalled for sterility concerns
- FDA-Device2026-07-22Argon Medical Devices Arterial Line Kit recalled for sterility test failure
- FDA-Device2026-07-22Argon Medical Devices One-Piece Introducer Tray recalled for sterility failure in Lidocaine ampules
- FDA-Device2026-07-22Argon Medical Devices T-Lok Bone Marrow Tray recalled for sterility failure
- FDA-Device2026-07-22Argon Medical Devices bone marrow tray kits recalled for sterility failure
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