Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Summary
The FDA issued a Class I for Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emerg by Mercury Enterprises, Inc. dba Mercury Medical. Reason: Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step..
Details
Source
Device Recall
External ID
Z-0004-2025
Action Date
2024-10-09
Status
Ongoing
Category
device
Product Description
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
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.
Quantity Affected: 1,300 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-30
Company
Clearwater, FL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 218 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Mercury Enterprises, Inc. dba Mercury Medical has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mercury Enterprises, Inc. dba Mercury Medical) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mercury Enterprises, Inc. dba Mercury Medical have FDA actions?
Mercury Enterprises, Inc. dba Mercury Medical has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0004-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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