PlainRecalls
FDA Devices Moderate Class II Terminated

SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537

Reported: June 14, 2023 Initiated: April 24, 2023 #Z-1686-2023

Product Description

SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537

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
45 cases (225 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?
SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537. Recalled by Avanos Medical, Inc.. Units affected: 45 cases (225 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-1686-2023.