Class I

Medical Device Recall: paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

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

3182 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3091-2024

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.

Smiths Medical ASD Inc. Medical Device Recall: paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N | SafeCheck