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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:128577

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 recall number

Z-2108-2014

Evidence summary

Product code
CAI
Recall status
Terminated
Event initiated
July 09, 2014
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2108-2014