According to the FDA, Baxter International Inc., of Deerfield, Illinois, has recalled certain lots of its Volara system single-patient use circuit and blue ventilator adapter assembly because of a potential device defect.
The company says it received reports of the product’s handset plug disconnecting from the blue ventilator adapter’s nebulizer port. Because the handset plug is essential in supporting “proper operation and ventilator gas flow” when using the Volara system with a ventilator and without a nebulizer attached to the blue ventilator adapter, a user may experience interrupted or delayed care if the handset plug disconnects without notice before or during therapy. In the case of such an event, which would allow the ventilator to leak gas flow from the blue ventilator adapter’s nebulizer port, the user may be subjected to reduce ventilation and and oxygenation.
While Baxter has not been made aware of any injuries or other adverse events connected to the potential problem to date, the company has since reached out to affected customers. Those in possession of devices under the recalled lots are asked to discontinue use of the patient circuits, and to contact Baxter to arrange for a return and replacement of the affected accessories.
In the event no other therapy option is available to a patient, the company says a patient circuit may continue to be used with caution. Prior to therapy, customers should do a careful visual inspection of the nebulizer port, and during therapy, the device should be evaluated for any ventilator gas flow leaks.
Announced on the FDA site on July 16, 2024, the Urgent Medical Device Recall covers the Volara system single-patient use circuit under product codes M08473 and M08474, as well as the blue ventilator adapter assembly under product code M07937. Affected accessories were made available for purchase and use across the United States from August 26, 2022 to December 30, 2023.
Customers with complaints regarding product quality or related adverse events are asked to report the incidents to Baxter Advanced Respiratory customer service at 800-426-4224. Representatives may be reached Monday through Friday, from 8:00 a.m. to 5:00 p.m. Central Time. Those seeking Acute Care Customer Service should select option 2; those seeking Home Care Customer Service should select option 3.
As the FDA continues to monitor this recall, users are encouraged to report any related issues to the agency’s MedWatch Serious Injury Reporting Program.
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