FDAClass IIJune 14, 2023

AVNS ambIT System - PIB/PCA W 2.5in Cath recall

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

Why was AVNS ambIT System - PIB/PCA W 2.5in Cath recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number (Expiration Date): 30181360 (17 Dec 2023), 30177648 (17 Dec 2023)

Product
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Recalling firm
Avanos Medical, Inc.
Quantity
33 cases (165 cassettes)
Distribution
Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
Recall date
June 14, 2023
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls