Recall Z-2108-2014— Teleflex Medical
Class II · Terminated
Class II FDA medical device recall by Teleflex Medical, initiated 2014-07-09, terminated 2017-03-09. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: The temperature probe does not properly connect to the temperature port..
- Recalling firm
- Teleflex Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-09
- Terminated
- 2017-03-09
- Firm location
- Durham, NC, United States
Product description
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.
Reason for recall
The temperature probe does not properly connect to the temperature port.
Data sourced from openFDA. This site is unofficial and independent of the FDA.