Drug recall
Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
FDA recall event 94713 · Class I · Baxter Healthcare Corporation
Key facts
| Event ID | 94713 |
|---|---|
| Recall numbers | Z-2321-2024, Z-2322-2024 |
| Recalling firm | Baxter Healthcare Corporation |
| Product type | Devices |
| Products | Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component., Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device. |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | May 30, 2024 |
| Report date | Jul 24, 2024 |
| City | Deerfield |
| State | IL |
| Country | United States |
| FEI number | 1417572 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: