Volara ventilator adapter recalled as Class I over desaturation and barotrauma
Baxter is issuing an urgent correction for the Blue Ventilator Adapter Module used with the Volara system because home users may be unaware of possible oxygen desaturation or lung injury from overexpansion.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The rubric states an FDA Class I recall is never scored below 4, and this record carries a Class I classification with no reported deaths in the source.
Plain-English summary
The Blue Ventilator Adapter Module, single-patient use circuit, product code M07937, an accessory to the Baxter Volara Respiratory Therapy system, is being recalled. About 19 units were distributed in Florida.
This is an Urgent Medical Device Correction for the Volara system single-patient use circuit, issued because of the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma), when the Volara device is used in the home care environment. The correction provides the home caregiver with specific instructions for use. The FDA has classified this recall as Class I, its most serious category.
Affected product carries UDI/DI number 00887761984622.
Users and caregivers can identify affected circuits by the product code and UDI above, and may contact the recalling firm for further information.
The recalled product
- Product
- Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 19
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 (1)
- UDI/DI number 00887761984622
Distribution
Distributed in 1 state:
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