FDA-Device2022-06-08Class I
In-Line ventilator adaptor
Baxter Healthcare Corporation
Hazard
There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
Sold states
US Nationwide distribution in the states of TX, FL, VA, KY, CA, AZ, WI, IL, NC, OH, MI, MS, MO, MN, AL, TN, SD, OK, NV, NJ, IN, CO, GA, WA, PA, IA, NE, NM, SC, ND, KS, WV, OR.
Affected count
259 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
In-Line ventilator adaptor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1138-2022Don't want to check this manually?
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