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Neo-Tee T-Piece Resuscitator. Part Numbers 1050805… recallZ-0004-2025 · Mercury Enterprises, Inc. dba Mercury Medical · initiated Aug 30, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Mercury Enterprises, Inc. dba Mercury Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-0004-2025
Status
Open, Classified
Initiated by the company
Aug 30, 2024
Posted by the FDA
Oct 2, 2024
Recalling firm
Mercury Enterprises, Inc. dba Mercury Medical
Quantity
1,300 units
Product code
BTL
FDA submissions
K093913
Distribution
US distribution to MI, FL, SC, PA, IN. International distribution to Albania.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

34 devices cleared under K093913 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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