Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A

FDA device recall Z-2704-2026 · posted 2026-07-10 · Open, Classified

Recall details

Recalling firm

Argon Medical Devices, Inc

Reason for recall

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Action taken

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 Arbee.cummings@argonmedical.com

Root cause

Material/Component Contamination

Status

Open, Classified

Product code

OEZ

Quantity affected

950

Distribution

Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.

Date initiated

2026-06-01

Date posted

2026-07-10

Location

Athens, TX