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softFlow
TNI medical AG · Model 40620600 · UDI-DI 04059163000620
BTT
Prescription
10
510(k) clearances
18,067
Adverse events (126 deaths)
70
Recalls
108
Facilities
Description
Accessories Set Clinic USA softFlow 50
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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Get your free API keyRead the docsData 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.