Device product
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Z-0004-2025
Product summary
- Event
- Event 95303
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1,300 units
- Official record key
device-enforcement:Z-0004-2025
Official wording
Reason: Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
Code information: Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805. Part Number: 1050832; UDI/DI: 10641043508329, 30641043508323; Lot Numbers: 2423550832, 2417850832.
Distribution pattern: US distribution to MI, FL, SC, PA, IN. International distribution to Albania.
Derived failure modes
-
Unknown
Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.