FDA-Device2023-06-14Class II
AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
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
57 cases (285 cassettes)
Manufactured in
5405 Windward Pkwy, Alpharetta, GA, United States
Products
AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1685-2023Don't want to check this manually?
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