FDA-Device2026-07-22Class IPROCESSING DEFECT
Argon Medical Devices One-Piece Introducer Tray recalled for sterility failure in Lidocaine ampules
What this means
Argon Medical Devices is recalling One-Piece Introducer Trays (REF 497455 and 497434) that contain Lidocaine HCL Injection ampules. The Lidocaine ampules in these kits did not meet sterility release criteria, meaning they were not verified as free from contamination before distribution.
- Check if you have introducer trays with REF 497434 or 497455 and expiration date 7/19/2027.
- Do not use affected kits; contact Argon Medical Devices for return instructions.
- If ampules were already used, contact your healthcare provider.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Affected count
200
Manufactured in
1445 Flat Creek Rd, Athens, TX, United States
Products
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2705-2026More Argon Medical Devices recalls
- FDA-Device2026-07-22Argon Medical Devices bone marrow tray kits recalled for sterility failure
- FDA-Device2026-07-22Argon Medical Devices T-Lok Bone Marrow Tray recalled for sterility failure
- FDA-Device2026-07-22Argon Medical Devices pacing electrode trays recalled for sterility failure in lidocaine ampules
- FDA-Device2026-07-22Argon Medical Devices Arterial Line Kit recalled for sterility test failure
- FDA-Device2026-07-22Argon Medical Devices General Biopsy Tray recalled for sterility concerns
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