Transvenous Pacing Electrode Tray recallZ-2704-2026 · Argon Medical Devices, Inc · initiated Jun 1, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Argon Medical Devices, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
FDA root cause category: Material/Component Contamination
What the company is doing
On 6/1/2026, correction notices were sent to customers who were asked to do the following: 1) Do not use the affected Lidocaine vials included in affected Kits and Sets in scope of this notice 2) Review your inventory for any product covered by this Medical Device Notification. If any items from the affected lot are identified: - Place a copy of this notice with the affected product - Apply the enclosed stickers to the packaging (kit) to clearly identify the item and remind users to discard affected lidocaine. 3) At the point of use, upon opening the kit, discard the affected Lidocaine vials in accordance with your facility's procedures. 4) Obtain Lidocaine separately through your facility pharmacy and prepare / administer it per institutional protocols prior to the procedure. 5) Complete and return the response form via email [email protected]
Recall details
- Recall number
- Z-2704-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 1, 2026
- Posted by the FDA
- Jul 10, 2026
- Recalling firm
- Argon Medical Devices, Inc
- Quantity
- 950
- Product code
- OEZ
- Distribution
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Product description
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Code information (models, lots, serial numbers)
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)
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Transvenous Pacing Electrode Tray 008416AArgon Medical Devices, Inc. · Cardiovascular Procedure Kit1 recall0 reports
- Transvenous Pacing Electrode Tray 008566AArgon Medical Devices, Inc. · Cardiovascular Procedure Kit1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 99069).
- Z-2705-2026 · Open, ClassifiedOne-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
- Z-2706-2026 · Open, ClassifiedGeneral Biospy Tray, REF: GUTS1000
- Z-2707-2026 · Open, ClassifiedT-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
- Z-2708-2026 · Open, ClassifiedArterial Line Kit 20ga x 6, REF: 400115A
- Z-2709-2026 · Open, ClassifiedBone Marrow Tray, REF: CB0033TL; CB0355TLA
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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