FDA recall Z-0004-2025

Mercury Enterprises, Inc. dba Mercury Medical · Class I · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-08-30
Report date
2024-10-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Clearwater, FL, United States

Primary source

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