Drug recall
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of…
FDA recall event 90433 · Class II · Breas Medical, Inc.
Key facts
| Event ID | 90433 |
|---|---|
| Recall numbers | Z-1382-2022 |
| Recalling firm | Breas Medical, Inc. |
| Product type | Devices |
| Products | Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 ¿ If the recalled product… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health… |
| Initiation date | Jun 2, 2022 |
| Report date | Jul 20, 2022 |
| City | North Billerica |
| State | MA |
| Country | United States |
| FEI number | 3010817335 |
At a glance
- 1–9 Products in this recall
- 1–9 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: