Z-0004-2025 Class I Ongoing

Recalled by Mercury Enterprises, Inc. dba Mercury Medical — Clearwater, FL

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.