Z-0004-2025 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2024
- Initiation Date
- August 30, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,300 units
Product Description
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Reason for Recall
Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
Distribution Pattern
US distribution to MI, FL, SC, PA, IN. International distribution to Albania.
Code Information
Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805. Part Number: 1050832; UDI/DI: 10641043508329, 30641043508323; Lot Numbers: 2423550832, 2417850832.