Device product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020M; 2) ECONO STERILE VEIN HOOK 2MM STERILE CS/25, Model Number 96-4021M; 3) ECONO STERILE VEIN HOOK 2.5MM STERILE CS/25, Model Number 96-4022M; venous procedures
Z-0935-2025
Product summary
- Event
- Event 95946
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1050 units
- Official record key
device-enforcement:Z-0935-2025
Official wording
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Code information: 1) 96-4020M, UDI/DI 50649111476356, Lot codes: SK-125; 2) 96-4021M, UDI/DI 50649111476363, Lot codes: SK-125, SK-128; 3) 96-4022M, UDI/DI 50649111476370, Lot codes: SK-125.
Distribution pattern: Domestic: Nationwide Distribution
Derived failure modes
-
Sterility assurance
breach of the sterile barrier