FDA recall Z-1684-2023

Avanos Medical, Inc. · Class II · device

Product

AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509

Reason for recall

Some of the ambIT kits were potentially distributed without an air in-line filter.

Distribution

Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.

Key facts

Status
Terminated
Initiation date
2023-04-24
Report date
2023-06-14
Termination date
2024-08-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1684-2023