Baxter Recalls Volara System Single-Patient Use Circuit

(RTTNews) - Baxter International Inc. has issued an urgent medical device recall for certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly, according to the U.S. Food and Drug Administration.

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

The recall involves Volara system single-patient use circuit with product codes M08473 and M08474, and the blue ventilator adapter assembly with product code M07937. The impacted accessories were distributed in the United States between August 26, 2022 and December 30, 2023.

According to the agency, the handset plug, when using the Volara system in-line with a ventilator and without a nebulizer connected to the blue ventilator adapter, is required to help ensure proper operation and ventilator gas flow.

If the handset plug disconnects and goes unnoticed prior to or during therapy, it may lead to an interruption or delay of care. This may result in reduced ventilation and oxygenation due to the ventilator leaking gas flow from the nebulizer port on the blue ventilator adapter.

However, the company has not received any reports of injuries in association with the issue so far.

Baxter has contacted affected customers, urging them to stop using the affected patient circuits and arrange for the return and replacement of the accessories.

Meanwhile, patients may continue to use it if another option for therapy is not available, but with caution.

Baxter last week had issued an urgent medical device recall for certain Life2000 ventilators citing potential damage to the attached battery charger dongle.

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