Device product
Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's sideport permits access for administration of artificial surfactant, airway pressure monitoring, gas sampling, and instillation of sterile saline for airway leakage.
Z-1641-2014
Product summary
- Event
- Event 67991
- Status
- Terminated
- Classification
- Class I
- Quantity
- 100 devices
- Official record key
device-enforcement:Z-1641-2014
Official wording
Reason: One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm.
Code information: Lot or Serial No: 2553426
Distribution pattern: US distribution in the state of North Carolina.
Derived failure modes
-
Unknown
One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm.