FDA-Device2023-06-14Class II
AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
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-1685-2023More 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
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief