PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 14, 2023 Initiated: April 24, 2023 #Z-1684-2023

Product Description

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.

Details

Recalling Firm
Avanos Medical, Inc.
Units Affected
33 cases (165 cassettes)
Distribution
Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
Location
Alpharetta, GA

Frequently Asked Questions

What product was recalled?
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509. Recalled by Avanos Medical, Inc.. Units affected: 33 cases (165 cassettes).
Why was this product recalled?
Some of the ambIT kits were potentially distributed without an air in-line filter.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 14, 2023. Severity: Moderate. Recall number: Z-1684-2023.