Z-2322-2024 Class I Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
July 24, 2024
Initiation Date
May 30, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
350 units

Product Description

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

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 Pattern

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

Code Information

Product Code: M07937; Lot numbers: 4210495, 4325617.