Device product
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)
Z-0926-2025
Product summary
- Event
- Event 95946
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 125 units
- Official record key
device-enforcement:Z-0926-2025
Official wording
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Code information: 1) 96-2483, UDI/DI 50649111449053, Lot codes: FSS5; 2) 96-2484, UDI/DI 50649111492950, Lot codes: SK-115
Distribution pattern: Domestic: Nationwide Distribution
Derived failure modes
-
Sterility assurance
breach of the sterile barrier