United StatesArgon Medical Devices is recalling multiple trays and kits — Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F (REF 008416A, 008566A), One‑Piece Introducer Tray (REF 497455, 497434), General Biopsy Tray (REF GUTS1000), T‑Lok Bone Marrow Tray (REF BMT1104STL, BMET1104TL, BMT1104CATL), Arterial Line Kit 20ga x 6 (REF 400115A), and Bone Marrow Tray (REF CB0033TL, CB0355TLA) — with the specified REF/UDI‑DI, lot and expiration codes listed in the notice. They were recalled because the kits contain Lidocaine HCl Injection USP 1% (10 mg/mL) 5 mL ampules that did not meet sterility release criteria.
What's being recalled
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
General Biospy Tray, REF: GUTS1000
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
Arterial Line Kit 20ga x 6, REF: 400115A
Bone Marrow Tray, REF: CB0033TL; CB0355TLA
Recalling firm: Argon Medical Devices, Inc, Athens, TX, United States.
How to identify it
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) REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027); REF/UDI-DI Box:Unit/Lot(Expiration): GUTS1000/20886333001594:00886333001590/11649760(3/31/2028) REF/UDI-DI Box:Unit/Lot(Expiration): BMT1104STL/20886333007862:00886333007868/11650679(11/30/2026); BMET1104TL/20886333007602:00886333007608/11654764(3/31/2028); BMT1104CATL/20886333007763:00886333007769/11650887(11/30/2026) REF/UDI-DI Box:Unit/Lot(Expiration): 400115A/20886333212884:00886333212880/11655174(7/19/2027), 11655183(7/19/2027), 11655185(7/19/2027), 11659131(7/19/2027); REF/UDI-DI Box:Unit/Lot(Expiration): CB0033TL/20886333217308:00886333217304/11650820(3/31/2028), 11652276(3/31/2028); CB0355TLA/20886333217698:00886333217694/11651977(3/31/2028);
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)