PlainRecalls
FDA Devices Moderate Class II Terminated

Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. 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.

Reported: July 30, 2014 Initiated: July 9, 2014 #Z-2107-2014

Product Description

Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. 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.

Reason for Recall

The temperature probe does not properly connect to the temperature port.

Details

Recalling Firm
Teleflex Medical
Units Affected
11,679 units
Distribution
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
Location
Durham, NC

Frequently Asked Questions

What product was recalled?
Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. 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.. Recalled by Teleflex Medical. Units affected: 11,679 units.
Why was this product recalled?
The temperature probe does not properly connect to the temperature port.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 30, 2014. Severity: Moderate. Recall number: Z-2107-2014.