|
|
Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement
Smiths Medical is correcting paraPAC Plus P300 and P310 ventilator due to a risk of inadvertent movement of the device’s tidal volume knob. When the knob is set at high (1000 - 1500 ml) or low (70 - 150 ml), the knob may move away from the original setting on its own. If the tidal volume knob moves, it may cause the patient to experience delayed therapy, too much tidal volume or not enough tidal volume.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves correcting devices, and does not involve removing them from where they are used or sold. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with questions about this recall should contact Smiths Medical Technical Support at 1-800-241-4002, option 3.
|
|
|
|
