The recall affects specific lots of the Volara system single-patient use circuit and blue ventilator adapter assembly due to a potential disconnection issue that could disrupt ventilation.

RT’s Three Key Takeaways:

1. Recall Due to Disconnection Issue: Baxter International Inc is recalling certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly due to reports of the handset plug disconnecting from the nebulizer port, which could lead to reduced ventilation and oxygenation.
2. Customer Notifications and Replacement: Baxter has contacted affected customers, advising them to stop using the affected products and arrange for their return and replacement, while instructing those without alternatives to use the products with caution and regularly check for ventilator gas flow leaks.
3. Regulatory Notification: The recall, which applies to products distributed in the United States between Aug 26, 2022, and Dec 30, 2023, has been reported to the US Food and Drug Administration by Baxter.

Baxter International Inc is recalling certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly due to reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter. 

No injuries have been reported in association with this issue to date. Baxter is working with customers to replace the affected products, according to a release from the company.

When using the Volara system in-line with a ventilator and without a nebulizer connected to the blue ventilator adapter, the handset plug 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.

Baxter has contacted affected customers, instructing them to stop using the affected patient circuits and arrange for the return and replacement of the accessories by contacting Baxter directly. If a patient does not have another option for therapy, they may continue to use it with caution. Customers are instructed to visually inspect the nebulizer port prior to therapy and check for any ventilator gas flow leaks for the duration of therapy.

The Urgent Medical Device Recall applies to the Volara system single-patient use circuit with product codes M08473 and M08474, and the blue ventilator adapter assembly, product code M07937. The impacted accessories were distributed in the United States between Aug 26, 2022, and Dec 30, 2023.

Baxter says it has notified the US Food and Drug Administration of this action.