FDA-Device2022-03-30Class II
Compella Therapy Air Supply Unit
Baxter Healthcare Corporation
Hazard
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Cameroon, Canada, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Jamaica, Jordan, Kuwait, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkmenistan, UAE, and UK.
Affected count
6022 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Compella Therapy Air Supply Unit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0821-2022Don't want to check this manually?
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