Recall Z-0821-2025— Mercury Enterprises, Inc. dba Mercury Medical

Name: FDA recall Z-0821-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-10

Class I · Ongoing

Class I FDA medical device recall by Mercury Enterprises, Inc. dba Mercury Medical, initiated 2024-12-10. It names one FDA 510(k) clearance: K093913. Product: Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842. Reason: Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient..

Recalling firm: Mercury Enterprises, Inc. dba Mercury Medical
Classification: Class I
Status: Ongoing
Initiated: 2024-12-10
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, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842

Reason for recall

Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient.

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