FDAFDA · Food and drugs·Recall number Z-0004-2025
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Published October 9, 2024 · Recall initiated: August 30, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Mercury Enterprises, Inc. dba Mercury Medical
- Distributor
- US distribution to MI, FL, SC, PA, IN. International distribution to Albania.
- Lot
- Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805. Part Number: 1050832; UDI/DI: 10641043508329, 30641043508323; Lot Numbers: 2423550832, 2417850832.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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