Argon Medical Devices, Inc: Dilator, Vessel, For Percutaneous Catheterization
- Recalling firm
- Argon Medical Devices, Inc
- Product
- One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
- 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/170a18a1-4f81-4d4f-8632-b7889c0b160e