FDAFDA · Food and drugs·Recall number Z-0930-2025
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
Published January 22, 2025 · Recall initiated: December 3, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reports of various packaging issues that may result in a breach of the sterile barrier.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sklar Instruments
- Distributor
- Domestic: Nationwide Distribution
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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