Z-0935-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2025
- Initiation Date
- December 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1050 units
Product Description
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
Reason for Recall
Reports of various packaging issues that may result in a breach of the sterile barrier.
Distribution Pattern
Domestic: Nationwide Distribution
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.