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HME-Booster T-Piece

FLEXICARE MEDICAL LIMITED · Model 360-000-000 · UDI-DI 05055788778554

BTT

510(k) clearances

18,067

Adverse events (126 deaths)

Recalls

108

Facilities

Recalls

Date	Firm	Reason
2026-07-13	Medline Industries, LP	Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke,
2025-09-18	Fisher & Paykel Healthcare, Ltd.	When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120
2024-04-02	Fisher & Paykel Healthcare, Ltd.	Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, interm
2022-12-16	Vapotherm	There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to
2021-01-05	Hamilton Medical AG	When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into th
2019-12-13	TELEFLEX MEDICAL INC	There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the c
2019-12-13	TELEFLEX MEDICAL INC	There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the c
2019-12-13	TELEFLEX MEDICAL INC	There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the c
2019-12-13	TELEFLEX MEDICAL INC	There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the c
2015-04-01	Teleflex Medical	Customer complaints were received of power to the unit ceasing and the display going blank.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.