FDAClass IOctober 9, 2024

Neo-Tee T-Piece Resuscitator recall

Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

Why was Neo-Tee T-Piece Resuscitator recalled?

Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805. Part Number: 1050832; UDI/DI: 10641043508329, 30641043508323; Lot Numbers: 2423550832, 2417850832.

Product
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Recalling firm
Mercury Enterprises, Inc. dba Mercury Medical
Quantity
1,300 units
Distribution
US distribution to MI, FL, SC, PA, IN. International distribution to Albania.
Recall date
October 9, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls