Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory ...
FDA Recall #Z-0004-2025 — Class I — August 30, 2024
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.
Recalling Firm
Mercury Enterprises, Inc. dba Mercury Medical — Clearwater, FL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
1,300 units
Distribution
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated