Device product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
Z-0927-2025
Product summary
- Event
- Event 95946
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 0 units
- Official record key
device-enforcement:Z-0927-2025
Official wording
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Code information: 941-0191, UDI/DI 50649111232730. Lot codes: 9249410191
Distribution pattern: Domestic: Nationwide Distribution
Derived failure modes
-
Sterility assurance
breach of the sterile barrier