Device product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO STERILE FRAZIER TUBE 7FR STERILE CS/25, Model Number 96-5435; 5) ECONO STERILE FRAZIER TUBE 8FR STERILE CS/25, Model Number 96-5436; 6) ECONO STERILE FRAZIER TUBE 9FR STERILE CS/25, Model Number 96-5437; 7) ECONO STERILE FRAZIER TUBE 10FR STERILE CS25, Model Number 96-5438; 8) ECONO STERILE FRAZIER TUBE 12FR STERILE CS25, Model Number 96-5439; 9) ECONO STERILE FRAZIER TUBE 14FR STERILE CS25, Model Number 96-5440; 10) ECONO STERILE BARON SUCT TUBE 3FR STER CS25, Model Number 96-5492; 11) ECONO STERILE BARON SUCT TUBE 5FR STER CS25, Model Number 96-5493; 12) ECONO STERILE BARON SUCT TUBE 7FR STER CS25, Model Number 96-5494; suction devices
Z-0938-2025
Product summary
- Event
- Event 95946
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 150 units
- Official record key
device-enforcement:Z-0938-2025
Official wording
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Code information: 1) 96-4176, UDI/DI 50649111493674, Lot codes: FSS4, FSS5; 2) 96-4177, UDI/DI 50649111493681, Lot codes: FSS4, FSS5; 3) 96-5434, UDI/DI 50649111493612, Lot codes: FSS4, FSS5; 4) 96-5435, UDI/DI 50649111493629, Lot codes: FSS4, FSS5, FSS6; 5) 96-5436, UDI/DI 50649111493636, Lot codes: FSS4, FSS5; 6) 96-5437, UDI/DI 50649111493643, Lot codes: FSS4, FSS5; 7) 96-5438, UDI/DI 50649111493650, Lot codes: FSS4, FSS5; 8) 96-5439, UDI/DI 50649111493667, Lot codes: FSS4, FSS5; 9) 96-5440, UDI/DI 50649111493964, Lot codes: FSS4, FSS5; 10) 96-5492, UDI/DI 50649111481657, Lot codes: FSS4, FSS5; 11) 96-5493, UDI/DI 50649111481664, Lot codes: FSS4, FSS5; 12) 96-5494, UDI/DI 50649111481671, Lot codes: FSS4, FSS5.
Distribution pattern: Domestic: Nationwide Distribution
Derived failure modes
-
Sterility assurance
breach of the sterile barrier