FDA-Device2024-07-24Class I
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
Baxter Healthcare Corporation
Hazard
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
Sold states
Nationwide distribution. International distribution to Canada, France, and Germany.
Affected count
58,220 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2321-2024Don't want to check this manually?
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