Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
This recall is currently active, issued October 2, 2024. It was issued by Mercury Enterprises, Inc. Dba Mercury Medical.
- Recall Initiated
- August 30, 2024
- Posted
- October 2, 2024
- Recall Number
- Z-0004-2025
- Quantity
- 1,300 units
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
Distribution
US distribution to MI, FL, SC, PA, IN. International distribution to Albania.
Lot / Code Info
Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805. Part Number: 1050832; UDI/DI: 10641043508329, 30641043508323; Lot Numbers: 2423550832, 2417850832.
Root Cause
Process control
Action Taken
Mercury Medical notified customers on 09/04/2024 via letter. Consignees who are medical facilities were instructed to immediately review inventory and quarantine any affected units on hand, contact customer service to arrange return of units, and complete the return response form. Consignees who are distributors were instructed to notify customers if further distributed, obtain a response form from those customers, arrange for any return of affected units, and complete the return response form.