Class I

Medical Device Recall: paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

Smiths Medical ASD Inc. · May 31, 2024

Reason for Recall

Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.

Distribution

Worldwide distribution.

Quantity Affected

11244 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3090-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.