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 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient.
Reason for recall: 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 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient. Distribution: US Nationwide distribution including in the states of TX, MS, LA, NC, TN, NY, FL, IL, UT, MT, OH, MI, NJ, AR, GA, WI, CA, IN, OK, CO, AL, SC, AZ, MD, WA, MO, PA, MA, NH, KY, KS, VA, CT, MN, ND, NM, NE, IA, WV, ID, NV, OR, HI, VT, RI, AL, SD, WY, PR, ME. Quantity: 51,144 Lot/code info: REF/UDI-DI: PT101US/9420012422347; PT100US/9420012422248. Disinfection Kit User Manual all revisions before UI-185043723 rev P
9420012422347, 9420012422248
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.