Z-2322-2024 Class I Ongoing
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.