Z-0930-2025 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
- 175 units
Product Description
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal 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) 96-2236, UDI/DI 50649111439757, Lot codes: SK-129, SK-130, SK-131; 2) 96-2237M, UDI/DI 50649111439764, Lot codes: SK-133; 3) 96-2238, UDI/DI 50649111439771, Lot codes: SK-131.