FDA-Device2014-07-30Class II
Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier.
Teleflex Medical
Hazard
The temperature probe does not properly connect to the temperature port.
Sold states
Worldwide Distribution - US including the states of CA, FL, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, PA, TN, TX and VA, and the countries of Argentina, Chile, Colombia, and the Philippines
Affected count
11,679 units
Manufactured in
4024 Stirrup Creek Dr, Durham, NC, United States
Products
Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2108-2014Don't want to check this manually?
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