FDA-Device2023-06-14Class II
SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
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-1686-2023More Avanos Medical, Inc. recalls
- FDA-Device2026-06-17Avanos Medical MIC Safety PEG Kit 24 Fr recalled for defective lidocaine injection
- FDA-Device2026-06-17Avanos CORFLO Safety PEG Kit recalled for defective lidocaine injection
- FDA-Device2026-06-17Avanos CORFLO Safety PEG Kit with ENFit Connector recalled for defective lidocaine injection
- FDA-Device2026-06-17Avanos MIC Safety PEG Kit recalled for defective lidocaine injection
- FDA-Device2026-06-17Avanos Medical MIC Safety PEG Kit recalled for defective lidocaine injection
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