Summary
The FDA issued a Class II for AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509 by Avanos Medical, Inc.. Reason: Some of the ambIT kits were potentially distributed without an air in-line filter..
Details
Source
Device Recall
External ID
Z-1684-2023
Action Date
2023-06-14
Status
Terminated
Category
device
Product Description
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Lot/Code Info: Lot Number (Expiration Date): 30181360 (17 Dec 2023), 30177648 (17 Dec 2023)
Quantity Affected: 33 cases (165 cassettes)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-24
Company
Alpharetta, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 139 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Avanos Medical, Inc. has 55 FDA actions in our database, including 51 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Avanos Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Avanos Medical, Inc. have FDA actions?
Avanos Medical, Inc. has 55 FDA actions in our database, including 51 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1684-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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