FX.co ★ Baxter Recalls Volara System Single-Patient Use Circuit

Baxter International Inc. has announced an urgent recall for specific lots of the Volara system's single-patient use circuit and blue ventilator adapter assembly, as confirmed by the U.S. Food and Drug Administration (FDA).

The recall follows reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter.

Affected products include the Volara system single-patient use circuit with product codes M08473 and M08474, and the blue ventilator adapter assembly with product code M07937. These were distributed in the U.S. between August 26, 2022, and December 30, 2023.

According to the FDA, the handset plug is crucial for proper operation and ventilator gas flow when the Volara system is used in-line with a ventilator and without a nebulizer attached to the blue ventilator adapter.

If the handset plug disconnects without being noticed before or during therapy, it could lead to interrupted or delayed care. This may result in reduced ventilation and oxygenation due to gas flow leakage from the nebulizer port.

To date, no injuries have been reported related to this issue.

Baxter has reached out to affected customers, advising them to cease using the impacted circuits and arrange for their return and replacement.

In the interim, patients may continue using the device if no alternative therapy options are available, but should do so with caution.

Last week, Baxter also issued an urgent recall for certain Life2000 ventilators due to potential damage to the attached battery charger dongle.