Volara System Blue Ventilator Adapter Module Handset Plug Disconnection
Baxter Healthcare is recalling 350 units of the Volara System Blue Ventilator Adapter Module because the handset plug may disconnect from the nebulizer port, disrupting ventilator gas flow. Affected units were distributed nationwide and internationally.
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: This is a Class I FDA recall, which requires a minimum severity score of 4. No illnesses or injuries have been reported, but the potential disconnection of a critical device component—the handset plug—could prevent proper ventilator gas flow and device operation.
Plain-English summary
Baxter Healthcare Corporation is recalling the Volara System Blue Ventilator Adapter Module, an intermittent positive pressure breathing (IPPB) device component. The recall affects 350 units with lot numbers 4210495 and 4325617, identified by product code M07937.
The handset plug on the blue ventilator adapter may disconnect from the nebulizer port during use. The handset plug is essential to the device's proper operation and delivery of ventilator gas flow. A disconnection could prevent the device from functioning as intended.
The affected devices were distributed nationwide and internationally to Canada, France, and Germany. This is a Class I FDA recall, the agency's most serious classification.
Consumers or healthcare facilities in possession of affected units should stop using them and contact Baxter Healthcare Corporation for replacement or further instructions.
The recalled product
- Product
- Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 350
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 (3)
- Product Code: M07937
- Lot numbers: 4210495
- 4325617.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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