Class 1 Device Recall Volara System

• Date Initiated by Firm: May 30, 2024
• Date Posted: July 17, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2322-2024
• Recall Event ID: 94713
• 510(K)Number: K192143 K200988
• Product Classification: Device, positive pressure breathing, intermittent - Product Code NHJ
• Product: Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
• Code Information: Product Code: M07937; Lot numbers: 4210495, 4325617.
• FEI Number: 1417572
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
• FDA Determined Cause: Device Design
• Action: Baxter Healthcare notified customers on about 05/30/2024 via letter sent first-class mail. The letter instructed facilities to immediately locate, isolate, and cease all use of the affected lot numbers, return affected units on hand, and complete and return the acknowledgement form. If the product was further distributed, they were instructed to notify customers if product was further distributed. The letter instructed patients to immediately locate, isolate, and cease all use of the affected lot numbers, return affected units on hand, however if they do not have other options in stock, in order to not delay therapy, you may continue to use with caution. Visually inspect the nebulizer port prior to therapy and assess for ventilator gas flow leaks for the duration of therapy. They were also instructed to complete and return the acknowledgement form.
• Quantity in Commerce: 350 units
• Distribution: Nationwide distribution. International distribution to Canada, France, and Germany.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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