Device product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe
Z-0953-2025
Product summary
- Event
- Event 95946
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2500 units
- Official record key
device-enforcement:Z-0953-2025
Official wording
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Code information: 1) 94-5923, UDI/DI 50649111181663, Lot codes: SK-115, SK-116; 2) 96-2361, UDI/DI 50649111392601, Lot codes: SK-115.
Distribution pattern: Domestic: Nationwide Distribution
Derived failure modes
-
Sterility assurance
breach of the sterile barrier