Hillrom VOLARA System patient circuits recalled for nebulizer cup leakage
Baxter Healthcare is recalling Hillrom VOLARA System patient circuits due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and ineffective medication delivery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a medical device. Class I recalls are inherently classified as Severe or Critical per the rubric; the hazard involves potential oxygen level drops during therapy, which represents significant risk of harm to patients dependent on the device for breathing support.
Plain-English summary
Baxter Healthcare Corporation is recalling the Hillrom VOLARA System P.CIRCUIT 5KIT AC single-patient-use circuits (Model/Catalog Number REF M08474) distributed worldwide in the United States and Canada. The recall affects 13,881 units with all lot numbers distributed beginning April 28, 2025.
Reports indicate air and medication leakage from the nebulizer cup during therapy. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Patients and healthcare providers currently using this device should contact Baxter Healthcare Corporation for instructions on how to proceed. The UDI for this product is 10887761981499.
The recalled product
- Product
- Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- leakage
- oxygen-deprivation
- treatment-delivery-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 10887761981499
- Lot Numbers: All lot numbers distributed beginning on 4/28/2025
Distribution
Distributed nationwide across the United States.
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