Hillrom VOLARA System P.CIRCUIT KIT recalled for nebulizer cup leakage risk
What this means
The nebulizer cup on Hillrom VOLARA System breathing circuits may not lock properly after medication is added, causing air and medication to leak during therapy. This leakage can reduce oxygen delivery to the patient and prevent the prescribed medication from being effectively inhaled.
- Stop using affected VOLARA P.CIRCUIT KIT units (Model REF M08085, all lots from April 28, 2025 onward).
- Check that the nebulizer cup is fully locked before starting therapy.
- Contact Hillrom or your equipment supplier for instructions or replacement.
- Report any leakage or oxygen level drops to your healthcare provider immediately.
The agency's original wording
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2548-2026More Baxter recalls
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