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U.S. Department of Health and Human Services

Class 1 Device Recall NeoTee TPiece Resuscitator

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 Class 1 Device Recall NeoTee TPiece Resuscitatorsee related information
Date Initiated by FirmAugust 30, 2024
Date PostedOctober 02, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0004-2025
Recall Event ID 95303
510(K)NumberK093913 
Product Classification Ventilator, emergency, powered (resuscitator) - Product Code BTL
ProductNeo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Code Information Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805. Part Number: 1050832; UDI/DI: 10641043508329, 30641043508323; Lot Numbers: 2423550832, 2417850832.
Recalling Firm/
Manufacturer		 Mercury Enterprises, Inc. dba Mercury Medical
11300 49th St N
Clearwater FL 33762-4807
For Additional Information Contact
727-573-0088
Manufacturer Reason
for Recall		Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
FDA Determined
Cause 2		Process control
ActionMercury 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.
Quantity in Commerce1,300 units
DistributionUS distribution to MI, FL, SC, PA, IN. International distribution to Albania.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BTL
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