FDA-Device2024-10-09Class I

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

Mercury Enterprises, Inc. dba Mercury Medical
Hazard

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

Sold states
US distribution to MI, FL, SC, PA, IN. International distribution to Albania.
Affected count
1,300 units
Manufactured in
11300 49th St N, N/A, Clearwater, FL, United States
Products
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0004-2025

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