Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.

FDA device recall Z-2322-2024 · posted 2024-07-17 · Open, Classified

Recall details

Recalling firm

Baxter Healthcare Corporation

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.

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.

Root cause

Device Design

Status

Open, Classified

Product code

NHJ

Quantity affected

350 units

Distribution

Nationwide distribution. International distribution to Canada, France, and Germany.

Date initiated

2024-05-30

Date posted

2024-07-17

Location

Deerfield, IL

Related 510(k) clearances