Z-2705-2026 Class I Ongoing
FDA device recall Z-2705-2026 was initiated by Argon Medical Devices, Inc on June 1, 2026 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 200.
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2026
- Initiation Date
- June 1, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200
Product Description
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
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.
Distribution Pattern
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Code Information
REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027);