Hillrom VOLARA System P.CIRCUIT 5KIT 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, allowing air and medication to leak during therapy. This leakage can reduce oxygen delivery to the patient and prevent medication from being administered as prescribed.
- If you use this device, contact your healthcare provider or Hillrom immediately
- Do not use the device until you receive instructions from your healthcare provider or Hillrom
- Check that the nebulizer cup is fully and firmly locked before starting therapy
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-2551-2026More Baxter recalls
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