Device product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO STERILE GRAVES SPEC STRL LG BX/25, Model Number 96-2607; 4) ECONO STERILE PEDERSON SPEC STERILE" SM BX/25, Model Number 96-2613; 5)ECONO STERILE PEDERSON SPEC STRL MD BX/25, Model Number 96-2615; 6) ECONO STERILE PEDERSON SPEC STRL LG BX/50, Model Number 96-2616; 7) ECONO STERILE PEDERSON SPEC STRL LG BX/25, Model Number 96-2617; 8) ECONO STERILE GRAVES VAG SPEC STRL MD CS/50, Model Number 96-3001; 9) ECONO STERILE GRAVES VAG SPEC STRL LG CS/50, Model Number 96-3002; speculum, gynecological
Z-0944-2025
Product summary
- Event
- Event 95946
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 475 units
- Official record key
device-enforcement:Z-0944-2025
Official wording
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Code information: 1) 96-2603, UDI/DI 50649111067233, Lot Codes: SK-119; 2) 96-2605, UDI/DI 50649111067622, Lot Codes: SK-119; 3) 96-2607, UDI/DI 50649111067967, Lot Codes: SK-119; 4) 96-2613, UDI/DI 50649111068964, Lot Codes: SK-119; 5) 96-2615, UDI/DI 50649111069343, Lot Codes: SK-119; 6) 96-2616, UDI/DI 50649111069572, Lot Codes: SK-119; 7) 96-2617, UDI/DI 50649111069886, Lot Codes: SK-119; 8) 96-3001, UDI/DI 50649111133884, Lot Codes: SK-119; 9) 96-3002, UDI/DI 50649111134058, Lot Codes: SK-119.
Distribution pattern: Domestic: Nationwide Distribution
Derived failure modes
-
Sterility assurance
breach of the sterile barrier