Argon Medical Devices, Inc: Cardiovascular Procedure Kit
Argon Medical Devices is recalling Transvenous Pacing Electrode Trays that contain Lidocaine HCL Injection ampules because the ampules do not meet sterility standards. The recall affects kits distributed nationwide in the U.S., Puerto Rico, Trinidad and Tobago. This is a Class II recall, meaning use of the product could cause serious adverse health effects or death.
- Recalling firm
- Argon Medical Devices, Inc
- Product
- Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
- Reason
- Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-01
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/1c9a057f-bd62-4ec6-b033-890cf949f478