Recall Z-2321-2024 ยท NHJ Device, Positive Pressure Breathing, Intermittent
Baxter Healthcare Corporation
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
| Date | Jul 17, 2024 (initiated May 30, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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, i |
| Quantity | 58,220 units |
| Distribution | Nationwide distribution. International distribution to Canada, France, and Germany. |
| FDA record | Open on fda.gov |