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Transvenous Pacing Electrode Tray
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MEDICAL DEVICE RECALLCRITICAL

Transvenous Pacing Electrode Tray

Argon recalls Transvenous Pacing Electrode Trays due to non-sterile lidocaine ampules in kits.

What to do

Check your inventory for the affected REF numbers 008416A and 008566A. Stop using the kits and contact Argon Medical Devices for instructions on returning the product and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-2704-2026
Agency
FDA
Firm
Argon Medical Devices, Inc
Recall ID
99069
Status
ONGOING

Why it was recalled

Argon Medical Devices is recalling Transvenous Pacing Electrode Trays with Bipolar Balloon Pacing Electrode 5F because kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules were recalled due to not meeting release criteria for sterility.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeRecall #UDI-DI
General Biospy Tray, REF: GUTS1000GUTS1000, 11649760, 2028Z-2706-202620886333001594, 00886333001590, 11649760
Arterial Line Kit 20ga x 6, REF: 400115A400115A, 11655174, 2027, 11655183, 11655185, 11659131Z-2708-202620886333212884, 00886333212880, 11655174, 11655183, 11655185, 11659131
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A008416A, 11656898, 2027Z-2704-202620886333217636, 00886333217632, 11656898, 20886333217643, 00886333217649, 11654475, 11654478
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular497434, 11656891, 2027Z-2705-202620886333214499, 00886333214495, 11656891, 20886333214635, 00886333214631, 11658984
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATLBMT1104STL, 11650679, 2026Z-2707-202620886333007862, 00886333007868, 11650679, 20886333007602, 00886333007608, 11654764, 20886333007763, 00886333007769, 11650887
Bone Marrow Tray, REF: CB0033TL; CB0355TLACB0033TL, 11650820, 2028, 11652276Z-2709-202620886333217308, 00886333217304, 11650820, 11652276, 20886333217698, 00886333217694, 11651977

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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All recalls from Argon Medical Devices, Inc

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification