Baxter Healthcare Corporation: Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Baxter Healthcare Corporation
- Product
- Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
- Reason / hazard
- Urgent Medical Device Correction for the Volara system single-patient use circuit due to 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. This correction is providing the home caregiver specific instructions for use.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Florida
- Recall initiated
- 2026-02-18
- Code info
- UDI/DI number 00887761984622
- Product quantity
- 19 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Deerfield
- State
- IL
- Country
- United States
- Event id
- 98458
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