Baxter International : Issues Urgent Medical Device Recall for Volara System Single-Patient Use Circuit

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DEERFIELD, Ill. - 2024-07-15

Baxter International Inc. (NYSE:BAX) 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 (see Figure 1). The recall is due to reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter. To date, there have been no injuries reported in association with this issue. Baxter is working with customers to replace the affected products.

Figure 1

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 has notified the U.S. Food and Drug Administration (FDA) of this action. Any product quality complaints or adverse events experienced with the use of these products may be reported using one of the following options:

• Contacting Baxter Advanced Respiratory customer service at 800-426-4224 between the hours of 8 a.m. and 5 p.m. Central Time, Monday through Friday. Select option 2 for Acute Care Customer Service or option 3 for Home Care Customer Service.
• Reporting to the FDA MedWatch Serious Injury Reporting Program:
  • Online: By completing and submitting the report online at: https://www.accessdata.fda.gov/scripts/medwatch/
  • Regular mail or fax: Download the form from https://www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and mail it to the address on the pre-addressed form, or submit by fax to 800-332-0178