Baxter Recalls Hillrom Volara Circuit Kits in Class I Action
Baxter International recalled Hillrom Volara System patient circuit kits after the FDA said a nebulizer cup could leak air and medication during therapy, designating the action Class I.
Baxter International (BAX), through recalling firm Baxter Healthcare Corporation, recalled the Hillrom Volara System P.CIRCUIT KIT (Single Patient Use Circuit), model REF M08085, in a recall the FDA classified as Class I.
Reports indicate air and medication leakage from the nebulizer cup during therapy with Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect delivery of the prescribed treatment, and the issue is tied to improper locking of the nebulizer cup after medication is added during setup. The recall, filed under number Z-2548-2024, is voluntary and firm-initiated, remains ongoing, and covers worldwide distribution across the U.S. and Canada.
The same report date produced two related recalls of other Volara circuit kit configurations, the P.CIRCUIT 5KIT AC (REF M08474) and the P.CIRCUIT KIT AC (REF M08473), both citing identical nebulizer cup leakage and improper-locking issues and carrying the same worldwide U.S.-Canada distribution. A fourth Volara circuit product, the P.CIRCUIT 5KIT (REF M08270), was also recalled for the same reason. In 2024, Baxter recalled earlier Volara System single-patient-use circuit kits over a separate defect, in which the handset plug could disconnect from the nebulizer port on the ventilator adapter, a component required for proper operation and ventilator gas flow.
The recalls affect Baxter's Front Line Care division within its Healthcare Systems & Technologies segment, where the company reported first-quarter 2024 sales of about $705 million, roughly flat on a reported basis, a result attributed in part to the timing of orders and planned portfolio exits. Baxter reported companywide sales from continuing operations of $2.7 billion for the quarter and reiterated its full-year outlook of flat to 1% reported sales growth.