Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
This recall is currently active, issued July 17, 2024. It was issued by Baxter Healthcare Corporation.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- May 30, 2024
- Posted
- July 17, 2024
- Recall Number
- Z-2322-2024
- Quantity
- 350 units
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide distribution. International distribution to Canada, France, and Germany.
Lot / Code Info
Product Code: M07937; Lot numbers: 4210495, 4325617.
Root Cause
Device Design
Action Taken
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.