Class 2 Device Recall AVNS ambIT System

• Date Initiated by Firm: April 24, 2023
• Date Posted: June 06, 2023
• Recall Status: Terminated on August 02, 2024
• Recall Number: Z-1687-2023
• Recall Event ID: 92279
• 510(K)Number: K162165
• Product Classification: Pump, infusion - Product Code FRN
• Product: SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
• Code Information: Lot Number (Expiration Date): 30191805 (17 Jan 2025)
• Recalling Firm/ Manufacturer: Avanos Medical, Inc.; 5405 Windward Pkwy; Alpharetta GA 30004-3894
• For Additional Information Contact: Lisa Clark; 470-448-5444
• Manufacturer Reason for Recall: Some of the ambIT kits were potentially distributed without an air in-line filter.
• FDA Determined Cause: Under Investigation by firm
• Action: Avanos Medical notified customers on 04/24/2023 via email. Customers were instructed to evaluate their inventory of products to determine if any of the impacted product codes were present in their facility. The letter provided information identifying the affected product. It was indicated to segregate and contact Avanos to coordinate return/destruction of impacted product. Additionally, customers were instructed to complete and return the Acknowledgement Form.
• Quantity in Commerce: 40 cases (200 cassettes)
• Distribution: Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN