Volara system single-patient use circuit and blue ventilator adapter assembly - recalled due to quality issues, USA

United States

Baxter International Inc. announced today it has issued an Urgent Medical Device Recall for certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly. The recall is due to reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter. The impacted accessories were distributed in the United States between Aug. 26, 2022 and Dec. 30, 2023.

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.

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.

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.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Baxter International Inc.
Brand name: Volara
Product recalled: Volara system single-patient use circuit and blue ventilator adapter assembly
Reason of the recall: Reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter
FDA Recall date: July 16, 2024

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-medical-device-recall-volar-system-single-patient-use-circuit
Source: FDA