FDAFDA · Food and drugs·Recall number Z-0927-2025
ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal 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
- 941-0191, UDI/DI 50649111232730. Lot codes: 9249410191
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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