FDADecember 10, 2024device

Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

mercury enterprises inc dba mercury medicalmercurymercury enterprises

UPCs

106410435080533064104350805710641043508084306410435080881064104350809130641043508095106410435081073064104350810110641043508114306410435081181064104350814530641043508149

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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