Drug recall
Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
FDA recall event 71100 · Class II · ResMed Ltd.
Key facts
| Event ID | 71100 |
|---|---|
| Recall numbers | Z-1750-2015 |
| Recalling firm | ResMed Ltd. |
| Product type | Devices |
| Products | Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. Inappropriate disabling of alarms in ventilator dependent patients can lead to hazards of… |
| Initiation date | May 5, 2015 |
| Report date | Jun 17, 2015 |
| Termination date | Apr 7, 2016 |
| City | Bella Vista, NSW |
| Country | Australia |
| FEI number | 3004604967 |
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: