Hillrom VOLARA System P.CIRCUIT KIT AC recalled for nebulizer cup leakage risk
What this means
The nebulizer cup on Hillrom VOLARA System patient circuits may not lock properly during setup, causing air and medication to leak during therapy. This leakage can reduce oxygen levels and prevent medications from being delivered as prescribed.
- If you use a VOLARA System P.CIRCUIT KIT AC (Model REF M08473), stop using it and contact your healthcare provider or equipment supplier.
- Check that the nebulizer cup is firmly locked before starting therapy.
- Contact Hillrom or your equipment supplier for further instructions or a replacement.
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-2550-2026More Baxter recalls
- FDA-Device2026-07-08Hillrom Volara P.Circuit 5Kit breathing device recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT 5KIT AC recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Baxter operating table head positioning adapter recalled for loosening risk
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