FDA recall Z-1685-2023

Product

AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507

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-1685-2023