Hillrom VOLARA System patient circuits recalled for nebulizer leakage risk
Baxter Healthcare is recalling Hillrom VOLARA System patient circuits due to reports of air and medication leakage from the nebulizer cup, which can reduce oxygen levels and prevent proper 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 reserved for situations where there is a reasonable probability that use of the product will cause serious adverse health consequences or death. The hazard (oxygen level drop and treatment delivery failure) in a patient using a respiratory therapy device meets the threshold for Severe per the rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling the Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473, a positive pressure breathing device used for oscillation lung expansion therapy. The recall affects 16,187 units distributed nationwide in the US and in Canada. All lot numbers distributed beginning on April 28, 2025 are included (UDI: 00887761981492).
Reports indicate that air and medication can leak from the nebulizer cup during therapy. The leakage occurs when the nebulizer cup is improperly locked after medication is added during user setup. This leakage can cause an oxygen level drop in the patient and result in ineffective nebulization, which may prevent the prescribed treatment from being delivered properly.
If you are using a Hillrom VOLARA System patient circuit, check that the nebulizer cup is properly locked after adding medication. Contact Baxter Healthcare Corporation or your healthcare provider for further instructions on how to proceed with your device.
The recalled product
- Product
- Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- oxygen-deprivation
- leakage
- ineffective-treatment
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: 00887761981492
- Lot Numbers: All lot numbers distributed beginning on 4/28/2025
Distribution
Distributed nationwide across the United States.
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