Class I

Medical Device Recall: Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.

Baxter Healthcare Corporation · May 30, 2024

Reason for Recall

Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.

Distribution

Nationwide distribution. International distribution to Canada, France, and Germany.

States Affected

NATIONWIDE

Quantity Affected

58,220 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2321-2024

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.