FDA-Device2023-06-14Class II

ambIT Cassette Filter Male Luer, Product Code: 220266

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
1155 total, 280 individually packaged
Manufactured in
5405 Windward Pkwy, Alpharetta, GA, United States
Products
ambIT Cassette Filter Male Luer, Product Code: 220266

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1688-2023

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