Recall Z-0004-2025— Mercury Enterprises, Inc. dba Mercury Medical

Name: FDA recall Z-0004-2025
Creator: U.S. Food and Drug Administration
Published: 2024-08-30

Class I · Ongoing

Class I FDA medical device recall by Mercury Enterprises, Inc. dba Mercury Medical, initiated 2024-08-30. It names one FDA 510(k) clearance: K093913. Product: Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.. Reason: Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step..

Recalling firm: Mercury Enterprises, Inc. dba Mercury Medical
Classification: Class I
Status: Ongoing
Initiated: 2024-08-30
Firm location: Clearwater, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K093913 — MERCURY MEDICAL T-PIECE RESUSCITATORMercury Medical, Inc.·cleared 2010-04-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.