FDA-Device2023-06-14Class II
SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
Avanos Medical, Inc.
Hazard
Some of the ambIT kits were potentially distributed without an air in-line filter.
Sold states
Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
Affected count
45 cases (225 cassettes)
Manufactured in
5405 Windward Pkwy, Alpharetta, GA, United States
Products
SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1686-2023Don't want to check this manually?
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