Official recall notice
FDA DeviceClass INotable
FDA Recall: One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
- Recall date
- 2026-07-22
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
Hazard
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Product description
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Affected products
REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027);